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Data monitoring committee

XZ Xin Zhao
JN Jumin Niu
CS Cong Shi
ZL Zhihui Liu
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The data monitoring committee (DMC) will be composed of clinical trial specialists, including a biostatistician, who are not associated with the study. The committee will meet at least twice a year, and all data obtained from the trial will be evaluated by the committee.

The DMC will review unblinded outcome data for safety and efficacy, and judge if there is evidence that either treatment is unsafe and the trial should be discontinued. The DMC will also advise the Trial Steering Committee of any evidence of unethical treatment or unacceptably serious adverse events.

The IBM Clinical Development Management System (IBM Corporation, Somers, New York), which is based on an EDC (Electronic Data Capture System), will be used to manage the data in this study.

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