Setti, Sharay E.
Das, Nikita
Raymick, James
Hanig, Joseph
Sarkar, Sumit http://orcid.org/0000-0001-6255-8809
Article History
Received: 5 August 2021
Accepted: 5 December 2021
First Online: 22 January 2022
Declarations
:
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All experimental procedures described here for rodent and human tissues were approved by the appropriate committees at the National Center for Toxicological Research/FDA, including the NCTR Office of Research, the Regulatory Compliance and Risk Management Director and the FDA Research Involving Human Subjects Committee (RIHSC). As determined by the FDA RIHSC, this study did not reach the definition of “Human Subject Research” at 45 CFR 46.102(f) and thus, 45 CFR Part 46 does not apply.
: None of the authors in this manuscript has any conflict of interest.
: This document has been reviewed in accordance with United States Food and Drug Administration (FDA) policy and approved for publication. Approval does not signify that the contents necessarily reflect the position or opinions of the FDA nor does mention of trade names or commercial products constitute endorsement or recommendation for use. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the FDA.