Ethical considerations
ADVERSE EVENT
Participants’ rights are fully protected in accordance with good practice ethical obligations. during every stage of the trial. Informed consent to participate will be designed in compliance with the GCP guidelines and Helsinki Declaration [Each participant and their primary caregiver will be assigned a unique ID, and their personal identification items will be removed and kept as a separate file with restricted password to protect the confidentiality. All study data will be collected and collated using only the ID. Formal ethical approval for conducting the trial has been obtained from Institutional Review Board (IRB) at Peking University (Approval number IRB00001052-21170). Any adverse event reports will be submitted to IRB, which will approve any protocol modifications as necessary.