The EMPA-CARD trial is conducting in accordance with the principles of the declaration of Helsinki and all subsequent revisions. The study was approved by the ethics committee of Zanjan university of Medical Sciences. All patients are provided with written informed consent by the investigators prior to the recruitment. Moreover, the study protocol was prospectively registered on the Iranian Registry of Clinical Trials (www.IRCT.ir, Identifier: IRCT20190412043247N2).
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