This trial had been registered before recruitment on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=55262 No.ChiCTR2000034313). We will conduct the principles of the Declaration of Helsinki (2004 version) during the trial. The study protocol also has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University before recruitment (Approval number: 2019-KL-108–01). This study is a randomized, placebo-controlled, blind trial. The study flowchat was shown in Figure Figure11.

Study flowchart.

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