Ethics approval and consent to participation
The study was approved by the Ethics Committee of Queen Savang Vadhana Memorial Hospital (QSVMH Number 015/2563; Date:30/03/2019), and receipt of the ClinicalTrials.gov ID was NCT05234840; Date 01/01/2019. All procedures and methods were carried out in accordance with a Declaration of Helsinki regulation and guidelines. Written informed consent was obtained from all participants and/or their legal guardian(s) before participation into the study.