Ethics approval and consent to participate
The study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital on January 17, 2021 (KY2020-150–02). All participants or their legal representatives provided written informed consent before enrollment. The trial was registered before patient enrollment at clinicaltrials.gov on December 31, 2020 (NCT04691128), and adhered to the Consolidated Standards of Reporting Trials guidelines and the Declaration of Helsinki.