Document is current

Article History

Received: 5 February 2024

Accepted: 17 June 2024

First Online: 22 June 2024

Declarations

:

: The study commenced on the 8th of June, 2022 and was conducted by Salus Research, Inc. in accordance with proposed guidelines for current good clinical practices (cGCP’s). The study was conducted in compliance with the United States Federal Regulations governing informed consent (21 CFR 50), Institutional Review Boards (21 CFR 56), clinical investigations, and applicable regulations governing sponsor and investigator conduct (21 CFR 312/812). The process was overseen and approved by U.S Institutional Review Board, Inc., 6400 SW Court, Miami, FL 33143. The study was completed on the 6th of July, 2022.

: The study subjects were informed that the information (deidentified) may be given to the FDA. It may also be given to governmental agencies in other countries. This is done so the sponsor can receive marketing approval for new products resulting from this research. The information may also be used to meet the reporting requirements of governmental agencies. The results of this research may be published in scientific journals or presented at medical meetings, but your identity will not be disclosed. The information may be reviewed by U.S.IRB, Inc., a group of people who perform independent review of research as required by regulations for protecting the rights and safety of research participants. A description of this clinical trial may be available on <u>,</u> as required by U.S. Law. This web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

: KRM, JLM, and RS have no competing interests. GD, BM, and DM have equity shares in Pontis Biologics, Inc. constitute as competing interests.