DON in pediatric cerebral malaria, a phase I/IIA dose-escalation safety study: study protocol for a clinical trial.

"Declarations Ethics approval and consent to participate {24}This study was initially approved by the National Health Sciences Research Committee in Malawi (20/04/2676) and the George Washington University IRB in the US (6017270069166886) on 28 May 2021. Written informed consent is obtained from all adult participants and parents/guardians of pediatric participants. Consent for publication {32}Not applicable. Competing interests {28}The authors declare that they have no competing interests. Competing interests {28} The authors declare that they have no competing interests."

"Funding {4} This trial is funded by a grant from the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases, US National Institutes of Health (U01AI155300), through Funding Mechanism: PAR-18–633. The funder had no role in study design, data collection, data analysis, data interpretation, or writing of this manuscript. The investigational product research and development was supported by the Intramural Research Program of the National Institutes of Health."

"Trial registration This trial was registered on ClinicalTrials.gov on 28 July 2022 (NCT05478720)."