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Table 2 Discontinuance criteria

From: Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR)

6. If a participant declines to participate in the trial or withdraws his/her consent

7. If a participant finds it challenging to visit the research institution due to relocation or hospital transfer

8. If participants did not meet the selection criteria or if they have violated the inclusion/exclusion criteria after the initiation of the study

9. If a participant is unable to continue the research due to the development of an adverse event according to the investigator’s discretion

10. If the investigator finds it challenging to continue the research due to worsening of the primary disease or complications

11. If the blind code is opened

12. If the investigator finds that it is appropriate to discontinue participation in the trial due to certain reasons

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Cardiovascular Diabetology

ISSN: 1475-2840