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The following procedures are proposed to ensure that research conduct complies with the protocols set out and agreed upon in applications to the LSHTM Research Ethics Committee and the above IRBs for EN-REACH study trials, as listed in Additional file 1.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate {24}"}},{"value":"Not applicable, as no identifying images or personal\/clinical details of participants are shown here, nor will they be included in the trial results reports.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication {32}"}},{"value":"The authors declare that they have no known competing financial conflicts or personal relationships that could have influenced the research in this protocol paper.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests {28}"}}],"article-number":"556"}}