Lessing, Juan N. https://orcid.org/0000-0001-9180-3842
McGarry, Kelly
Schiffman, Fred
Austin, Matthew
Hepokoski, Mark
Keniston, Angela
Tammaro, Dominick
Finn, Kathleen M.
Article History
Received: 16 February 2021
Accepted: 24 June 2021
First Online: 28 September 2021
Declarations
:
: This study and its protocol (Number: 18-AAIM-101) were submitted to Pearl IRB (registered with the US Department of Health and Human Services Office for Human Research Protections as IRB00007772) for exemption determination in accordance with FDA 21 CFR 56.104 and DHHS 45 CFR 46.101 regulations and were deemed exempt under 45 CFR 46.101(b) category 2.