Funding for this research was provided by:
U.S. Food and Drug Administration (HHSF223200910006I)
Received: 8 January 2019
Accepted: 18 November 2019
First Online: 27 November 2019
Ethics approval and consent to participate
: This project was conducted under FDA’s public health authority and as such was not under the purview of the Institutional Review Board.
: KM, MER, ST, CK, KH have no competing interests to report. SEA has received grant support from Pfizer Inc.