Ethics
This trial was approved by the independent Institutional Ethics Committee of Xuanwu Hospital (Chairperson Prof. Yanghai Cui, identifier: IRB-XWAD-202008–12) on 12 /08/2020. The trial was also registered in the ClinicalTrial.gov registry (identifier: NCT04675372)(Sponsors: China International Neuroscience Institution) on 19/12 /2020. This randomised, double-blind, parallel-group clinical trial was designed, implemented, executed and overseen by the study sponsor and steering committee. Written informed consent was obtained from all study participants before enrolment. The study was conducted in accordance with the good clinical practice guidelines indicated in the Declaration of Helsinki and relevant regulatory requirements [