Yang, Xinxin http://orcid.org/0000-0002-5162-5030
Wipperman, Matthew F. http://orcid.org/0000-0003-1436-3366
Nachman, Sharon http://orcid.org/0000-0003-1665-7253
Sampson, Nicole S. http://orcid.org/0000-0002-2835-7760
Funding for this research was provided by:
National Heart, Lung, and Blood Institute (U01HL127522, U01HL127522)
National Institute of Allergy and Infectious Diseases (R41AI136071, UM1AI068632, R41AI136071)
National Center for Advancing Translational Sciences (TL1TR002386)
Article History
Received: 2 April 2021
Accepted: 8 February 2022
First Online: 17 February 2022
Declarations
:
: All methods were carried out in accordance with relevant guidelines and regulations. The NIH-IMPAACT Scientific Leadership Group (SLG) reviewed and approved the use of P1041 trial samples under NWCS127. The Wits Health Consortium, University of Witwatersrand, South Africa provided deidentified samples to Stony Brook University for which informed consent had been obtained from a parent and/or legal guardian of all participants. The Stony Brook University CORIHS determined the experiments (IRB# 687246-1) in this manuscript were not human subjects research (exemption 4) under either United States Department of Health and Human Services 45 CFR part 46, subpart A, “the Common Rule” or United States Food and Drug Administration (FDA) Regulations 21 CFR parts 50, 56, 312 and 812.
: Not applicable.
: NSS is President and co-owner of Chronus Pharmaceuticals, Inc. XY was an employee of both Chronus Pharmaceuticals, Inc and Stony Brook University. All intellectual property is currently owned by Stony Brook University. SN and MFW have no conflict of interest.