affiliation not provided to SSRN, affiliation not provided to SSRN, Joint Clinical Research Centre, Moi University, affiliation not provided to SSRN, Enhancing Care Foundation, University College London - MRC Clinical Trials Unit, Joint Clinical Research Centre, University of Zimbabwe - Clinical Trials Research Centre, Moi University, University of KwaZulu-Natal, Fondazione Penta ETS, affiliation not provided to SSRN, London School of Hygiene & Tropical Medicine - Department of Global Health and Development, Baylor University - Children's Foundation Uganda, Joint Clinical Research Centre, Radboud University Nijmegen - Radboud University Medical Center, Radboud University Nijmegen - Radboud University Medical Center, University of York, University College London - Infection, Immunity and Inflammation Research & Teaching Department, University College London - MRC Clinical Trials Unit, Baylor University - Children's Foundation Uganda, affiliation not provided to SSRN, University College London - MRC Clinical Trials Unit, affiliation not provided to SSRN, University College London - MRC Clinical Trials Unit, Baylor University - Children's Foundation Uganda and University College London - MRC Clinical Trials Unit