Trial design
The multi-center, non-inferiority, open-label, randomized controlled trial was conducted at Chulabhorn Hospital, Bangkok, and Prachathiput Hospital, Pathum Thani, Thailand. The trial followed the Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. The Ethics Committee approved the study for Human Research, Chulabhorn Research Institute, no. 192/2564. The trial protocol was registered in the Thai clinical trials registry no. 20220319002.