Ethics approval and consent to participate
The trial is conducted in accordance with the International Conference on Harmonization Good Clinical Practice (ICH-GCP) and adheres to the principles of the Helsinki declaration and regulatory guidelines in Mali. LAKANA has received approval from the Mali IRB, the Comité d'Éthique de la Faculté de Médecine, de Pharmacie et d’Odonto-Stomatologie (FMPOS), Université des Sciences, des Techniques et des Technologies de Bamako. An ethics committee in Finland has no legal mandate to authorize trials abroad, but the LAKANA trial has received a favorable opinion from the Ethics Committee of the Pirkanmaa Hospital District for Tampere University researchers to participate in the project.