Smart, Luke R. http://orcid.org/0000-0003-4083-0060
Segbefia, Catherine I.
Latham, Teresa S.
Stuber, Susan E.
Amissah-Arthur, Kwesi N.
Dzefi-Tettey, Klenam
Lane, Adam C.
Dei-Adomakoh, Yvonne A.
Ware, Russell E.
Funding for this research was provided by:
Addmedica Inc.
Article History
Received: 30 March 2023
Accepted: 13 September 2023
First Online: 22 September 2023
Declarations
:
: Ethical approval was obtained from the KBTH IRB (KBTH-IRB #0095/2021) in Ghana as well as the regulatory authority for clinical trial authorisation, the Ghana FDA (FDA/HPT/SMC/CTD/CTA/22/0047). The study was also approved by the CCHMC IRB (2021–0520), but the KBTH boards have primary oversight. Written informed consent will be obtained from all patients age > 17 years. For those ≤ 17 years, consent will be obtained from a parent or guardian. For those ages 10–17 years, assent will be obtained. Any child who reach 18 years of age while enrolled in the trial will be re-consented as adults.
: No details, images, or videos relating to an individual person are submitted with this manuscript. For future manuscripts, potential trial participants and/or authorised surrogates are informed during the consent process that de-identified trial information may be published.
: ACL has no competing interests.CIS has no competing interests.KDT has no competing interests.KNA receives grant funding from Optos Inc. (RIS 1065442) and NIH—H3 Eyes of Africa (5U54HG009826).LRS has no competing interests.REW is consultant for Nova Laboratories; receives research donations from Bristol Myers-Squibb, Addmedica, and Hemex Health; and chairs Data and Safety Monitoring Boards for Novartis and Editas.SES is a consultant for the American Society of Hematology Research Collaboration.TSL has no competing interests.YAD has no competing interests.