Ethics statement
Approval was obtained from the independent ethics committee at the Faculty of Medicine, University of Khartoum and the Sudanese National Medicines and Poisons Board. The study was conducted in accordance with the Declaration of Helsinki, with the International Council for Harmonization Good Clinical Practice (GCP) guidelines, and following all applicable state, local, and foreign laws for protecting the rights and welfare of human subjects. Informed consent and assent (when applicable) were obtained as per regulatory requirements. Written voluntary informed consent was obtained from adult patients and from the parent or guardian of any child <18 years old; assent from minors was also obtained according to country regulations.