Ann Abraham, Debi
Narasimhan, Udayakumar
Christy, Senta
Muhasaparur Ganesan, Rajanandh https://orcid.org/0000-0002-8547-4541
Article History
Received: 17 September 2020
Accepted: 30 October 2020
First Online: 10 November 2020
Compliance with ethical standards
:
: The authors have indicated that they have no conflicts of interest regarding the content of this article.
: The study was approved by the Human Institutional Ethical Committee (IEC) of SRIHER before the commencement of the study (Ethical clearance number: IEC/19/JUN/151/39) and the study was registered in the Clinical Trial Registry-India (CTRI/2019/07/020102). Written informed consent was obtained from the parents and the study was conducted according to the 2018 amendment of the International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines.