2.1. Study Design
COA No.
The study protocol received approval from the Institutional Review Board of Siriraj Hospital, Mahidol University (COA No. Si 322/2017), and was registered with Clinicaltrials.gov (Protocol NCT04896996) accessed on 11 October 2023. Written informed consent was obtained from the parents or legal guardians of the participating children prior to commencing the study, with their identities being kept confidential. A previous study described the participants’ flowchart and interventions [