Study ethics
The protocol, protocol amendments, and other relevant documents were submitted to, reviewed, and approved by the HOUEIKAI Institutional Review Board before study initiation. The study was conducted in accordance with the consensus ethical principles derived from international guidelines, including the Declaration of Helsinki, Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Ordinance on Good Clinical Practice Guidelines, and applicable laws and regulations. All subjects provided written informed consent for study participation.