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Authors
Bose, Adrita
Sardar, Syamal
Pal, Somnath
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Clinical Trials BETA
Clinical trials referenced in this document:
ctri/2023/12/060931 at Clinical Trials Registry IndiaDocuments that mention this clinical trial
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Article History
Received: 4 January 2025
Accepted: 15 July 2025
First Online: 21 October 2025
Declarations
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: The Institutional Ethics Committee of IPGMER in Kolkata, India, approved the study protocol (IPGME&R/IEC/2023/691) and was registered in the Clinical Trial Registry of India (CTRI/2023/12/060931). Informed consent was obtained from participants’ parents.
: Participant information sheets and informed consent forms were distributed to the parents of each eligible infant in both English and the local language. Parents were given sufficient time to understand the nature of the intervention, ask questions, and clarify doubts. Informed consent was obtained from the parents of all participants involved in the study.
: Consent for publication was obtained from the informed consent form. All the data were anonymized.
: The authors declare no competing interests.
