Ethics approval and consent to participate
Prior to study initiation, the protocol and all other appropriate documents were reviewed and approved by an Independent Ethics Committee and local regulatory authorities. The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki, the International Conference on Harmonisation for Good Clinical Practice guidance, and all local and regional applicable laws and regulations. Prior to the performance of any study-related assessments and procedures, all participants signed a written informed consent form with details of the trial treatment, procedures, and potential risks.