The protocol, consent forms, and questionnaires were approved by the CISM local ethics committee, the Ethics Committee of the Hospital Clínic of Barcelona (HCB/2015/0122), the National Bioethics Committee of Mozambique (CNBS; Ref. 173/CNBS/13) and the Mozambican Pharmaceutical Department (Ref./No. 4110/380/DF2014) before their implementation. All participants signed an informed consent form prior to the initiation of any study related activities. The clinical trial was registered at www.ClinicalTrials.gov (NCT02698748).
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