Ethical considerations
ADVERSE EVENTS
This study was approved by the School of Medicine Research and Ethics Committee of Makerere University, Kampala Uganda (#REC REF2019-013) and the Uganda National Council of Science and Technology (SS4927). Consultative approval was obtained from the Danish National Committee on Biomedical Research Ethics (1906848). The study was registered in the ISRCTN registry (ISRCTN13093195) and conducted in accordance with the principles of the Helsinki Declaration and local guidelines for human research. Oral and written information was provided in Lusoga, Luganda or English. Before caregivers gave written informed consent, their understanding was evaluated by a second staff member, using a questionnaire. An independent data safety and monitoring board conducted interim safety evaluations based on reports of adverse events and reasons for any early termination.