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The REC approvals at the following recruiting centres have already been obtained: Calicut Medical College, Kerala, India (IRC\/2015\/Protocol\/57; 12 June 2015); Indira Gandhi Institute of Child Health, Bangalore, India (IEC01062015; 1 June 2015); Lokmanya Tilak Municipal Medical College staff and research society (IEC\/30\/15; 17 June 2015); Madras Medical College Institutional Ethics Committee (IEC08072015; 7 July 2015); Maulana Azad Medical College Institutional Ethics Committee (IEC\/MAMC\/52\/1\/2016; 30 March 2016); Bangabandhu Sheikh Mujib Medical University Institutional Review Board (BSMMU\/2016\/6885; 29 June 2016); and Ethics Review Committee, University of Kelaniya (P\/109\/03\/2017; 3 April 2017) (Table\u00a0). The Health Ministry\u2019s Screening Committee (HMSC) of India and the Indian Council of Medical Research (ICMR) have also approved the proposal. All original trial documentation and any subsequent amendments will be approved by the Sponsor (Imperial College London) and by the relevant ethical bodies, before their implementation. Informed written parental consent will be obtained from parents of next kin of recruited babies and the consenting process will be video-recorded.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Written informed consent was obtained from the parents for publication of their individual details and any accompanying images in this manuscript. The consent form is held by the authors and in the patients\u2019 clinical notes and is available for review by the Editor-in-Chief.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Publisher\u2019s Note"}}],"article-number":"432"}}