Ethics statement
The research was designed and conducted in accordance with the current “Good Clinical Practice (GCP) of China”, “The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)-GCP”, “Guidelines for Ethical Review of Drug Clinical Trials” and “Declaration of Helsinki”. Clinical trial protocol revision and implementation were approved and supervised by the Hospital Ethics Committee. The protocol of the clinical study was approved by the Ethics Committee of Beijing You’an Hospital affiliated with Capital Medical University on September 5, 2019. The study recruited the first subject on December 2, 2019, and enrolled the last participant on June 25, 2021.The study has completed registration in the drug clinical trial registration and information disclosure platform, which is the legal registration platform for clinical information used by the drug evaluation center of the state medical products administration of China. The clinical trial record number is CTR20192280 in China. At present, the study has completed registration in the Chinese Clinical Trial Registry (ChiCTR), and the clinical trial record number is ChiCTR2200058122.