Ethics approval and consent to participate
The Institutional Review Board of Nanjing Drum Tower Hospital approved the study and protocol (approval number: 2020–293-02). The trial was conducted in accordance with the ethical principles of the “Declaration of Helsinki,” the International Conference on Harmonisation–Good Clinical Practice (ICH-GCP) guideline, the “Quality Management Standards for Drug Clinical Trials” of the Chinese Food and Drug Administration (CFDA), the “Medical Devices Clinical Trial Quality Management Standards” of the CFDA, the “Ethical Review Measures for Biomedical Research Involving Humans” of the National Health Commission of China, and other relevant national laws and regulations. Informed consent by the study participant or a legally authorized representative was given prior to inclusion in the study.