Ethics approval and consent to participate
CRB
The MiroCIP study was preapproved by the Chiba University Certified Clinical Research Review Board (CRB no. CRB3180015), which notified all participating centers of the approval.The study was carried out in accordance with the Clinical Research Act in Japan; the CRB conducted a central review, and after the study had been approved by the CRB, investigators at each site obtained permission from their administrator to start the research. Involvement of an ethical review committee at each facility is not required by the Clinical Research Act. The study was also conducted in accordance with the ethical principles, clinical research laws, and relevant notifications stipulated in the Declaration of Helsinki (as revised in 2013).Written informed consent was obtained from each patient after investigators had explained what participation in the MiroCIP study entailed, ensuring that they had the required understanding of the study procedures before agreeing to participation.