Study design
An investigator-initiated, multicenter, randomized, open, parallel-controlled trial was conducted from June 2019 to January 2022 at five hospitals in China: (1) Xiangyang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science (Xiangyang, Hubei); (2) 3201 Hospital of Xi’an Jiao Tong University Health Science Center (Xi’an, Shaanxi); (3) Number 1 Hospital of Yulin (Yulin, Shaanxi); (4) Tangdu Hospital, Air Force Medical University (Xi’an, Shaanxi); (5) Xi’an Daxing Hospital (Xi’an, Shaanxi). The study is reported according to CONSORT guidelines in The study protocol was approved (XYSZXYY-LLDD-PJ-2019-032) by the Ethics Committee of Xiangyang Central Hospital and was aligned with the Declaration of Helsinki 1964 and its later amendments. All participants provided written informed consent. The protocol has been registered (ChiCTR1900023884) in the clinical registry of China and has been published in advance [