ETHICAL APPROVAL STATEMENT AND CLINICAL TRIAL REGISTRATION NUMBER
Ethical approval for the trial was obtained from the Medical Ethics Committee of Xinhua Hospital Affiliated with Shanghai Jiao Tong University Medical College, and the implementation of this trial was in accordance with the Quality Management Standards for Drug Clinical Trials, the Declaration of Helsinki and relevant Chinese laws and regulations. All patients provided written informed consent before enrolment. This trial was registered in the International Standard Randomized Controlled Trial Number (ISRCTN, 