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Musa, Eltahir A.G. Khalil, Mahmoud Mudawi, Brima M. Younis, Asrat Hailu, Zewdu Hurissa, Workagegnehu Hailu, Samson Tesfaye, Eyasu Makonnen, Yalemtsehay Mekonnen, Alwin D.R. Huitema, Jos H. Beijnen, Smita A. Kshirsagar, Jaya Chakravarty, Madhukar Rai, Shyam Sundar, Fabiana Alves and Thomas P.C. Dorlo have no conflicts of interest to declare related to this study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The Eastern African clinical study was funded by M\u00e9decins Sans Fronti\u00e8res (MSF) and the Drugs for Neglected Diseases initiative (DNDi). The authors would like to thank the following donors for their support: Department for International Development (DFID), UK; M\u00e9decins Sans Fronti\u00e8res\/Doctors without Borders, International; Ministry of Foreign and European Affairs (MAEE), France; Region of Tuscany, Italy; R\u00e9publique and Canton de Geneva, Switzerland; Medicor Foundation, Liechtenstein; Fondation Pro Victimis, Switzerland; Fondation Andr\u00e9 and Cyprien, Switzerland; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; and private foundations and individual donors. The Indian clinical study was supported by the Bill and Melinda Gates Foundation, the Institute for One World Health, the Special Program for Research and Training in Tropical Diseases (TDR) of the United Nations Development Program, the World Bank, and the WHO. The current pharmacokinetic analysis was part of the EDCTP2 programme supported by the European Union (grant number RIA2016S1635-AfriKADIA). TPCD received funding from ZonMw\/Dutch Research Council (NWO) [project number 91617140].","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The NONMEM control stream can be found in ESM 3. For availability of the datasets analysed during the current study, please contact the corresponding author.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"All procedures were conducted in accordance with the Declaration of Helsinki (2002 version) relating to the conduct of research on human subjects, and followed the International Committee on Harmonization guidelines for the conduct of clinical trials. The relevant Ethics Committees from each country approved the clinical studies. Patients or their legal guardians (if they were minors) provided signed informed consent prior to being randomized to the different treatment arms. In India, patients were randomly assigned to the pharmacokinetic substudy, while in Eastern Africa, patients were asked to participate in the pharmacokinetic substudy using a separate informed consent.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval and informed consent"}},{"value":"All authors participated in the collection of the study data, interpretation of the study results, and drafting, critical revision and approval of the final version of the manuscript. LV, AH, FA, and TD were involved in the design of the analysis. LV and TD were responsible for data analysis and a draft of the first version of the manuscript.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent For Publication"}}]}}