Ethics approval and consent to participate
Ethical approval has been obtained from the Peking University Institutional Review Board (referenceIRB00001052-21170). The study will be conducted in accordance with the recommendations for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. Any major protocol amendments will be reported to all ethics committees and not implemented until approval is received. All approved amendments will be reported to the sponsor, trial registry and clinical monitor.