2.9. Ethical Considerations
This study was approved by the National Ethics Committee of Burkina Faso (deliberation number 2015-12-00) and the national clinical trials board of Burkina Faso (Direction Générale de la Pharmacie, du Médicament et des Laboratoires (DGPML)). The trial was registered in the International Standard Randomized Controlled Trial Number (ISRCTN) registry as ISRCTN50039021. A second approval was obtained in October 2020 from the National Ethics Committee of Burkina Faso (N°2020/000148/MS/MESRSI/CERS) to analyze remaining sera for vitamin B12 analyses.