2.1 Ethical approval of the study protocol
The study protocol was approved (approval number, 2021ZDSYLL195-P01) by the Ethics Committee of the Zhongda Hospital, Medical School, Southeast University (Nanjing, China). The study was conducted in accordance with the tenets of the Declaration of Helsinki 1964 and its later amendments and Good Clinical Practice guidelines. All participants provided written. The study was registered with the Clinical Trials Registry on 26 August 2020 (NCT 05041920).