Institutional review board and informed consent statement
The study protocol was approved by the Institutional Review Board of the Chulabhorn Research Institute (approval date: 28/08/2020, IRB number: 062/2563) and also registered with the Thai Clinical Trials Registry (approval date: 01/02/2021, TCTR20210201005). All clinical procedures were performed in compliance with the International Conference on Harmonization-Good Clinical Practice (GCP) under the Declaration of Helsinki. Informed consent was obtained from all subjects involved in the study.