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The protocol was approved by the Institutional Review Board (IRB) of University of Toyama (No. Rin 29-93) and all participating institutions. This trial is registered on the UMIN Clinical Trials Registry (UMIN000029647) and on ClinicalTrials.gov (NCT03331718). All subjects for this study will be provided with a consent form describing this study and containing sufficient information for subjects to make an informed decision about their participation in this study. 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