2.1. Ethical Aspects and Setting
The protocol of this study (MU-CIRB 2021/275.1905) was approved by Mahidol University Central. Institutional Review Board (MU-CIRB), approval number COA No.MU-CIRB2020/150.2406. This research was performed according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (ICH-GCP) and the Declaration of Helsinki. Informed written consent was obtained from each participant before the study commenced. The protocol was registered in the Thai Clinical Trial Registry (TCTR20230103004) and can be accessed at 