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Article History

Received: 14 June 2024

Accepted: 25 October 2024

First Online: 3 December 2024

Declarations

:

: All animal experiments were performed under approval of Sigmovir's Institutional Animal Care and Use Committee. The clinical trial was conducted in accordance with the principles of the Declaration of Helsinki, and Good Clinical Practice guidelines of the ICH, and all applicable sections of the US CFR, 21 CFR Parts 50, 56, and 312. The trial protocol was approved by IRB of AdvarraTM (Columbia, MD, US). All participants provided written informed consent. This trial was registered with Clinical Trials.gov NCT05118386.

: Not applicable.

: ABo, ML, SW, ABA, JTW, MS, and MWD are employees of Bill & Melinda Gates Medical Research Institute; DT is a former employee of PPD Inc and received funding to PPD Inc from Bill & Melinda Gates Medical Research Institute, DT is currently an employee of Boehringer Ingelheim and reports stocks/bonds from Sanara Medtech Inc; LMS and JA are former employees of Bill & Melinda Gates Medical Research Institute; HR and ABa are former employees of Arsanis Biosciences and report stocks/bonds from X4 Pharmaceuticals; AR is an employee of intiGROWTH LLC and received funding to intiGROWTH LLC from Bill & Melinda Gates Medical Research Institute; JT is employed by University Medical Centre Utrecht and received funding to University Medical Centre Utrecht from Bill & Melinda Gates Medical Research Institute.