Study design
This prospective, multicenter, open-label, exposure-variable study was
carried out at the Samsung Medical Center (Seoul, Korea), Seoul National
University Hospital (Seoul, Korea), and Yangsan Pusan National
University Hospital (Yangsan, Busan) between August 2016 and June 2018.
The study was carried out in accordance with the Declaration of Helsinki
and was registered at ClinicalTrials.gov (NCT 02882113). The protocol of
the study was approved by the Institutional Review Boards at the Samsung
Medical Center (IRB No. 2015-11-140), Seoul National University Hospital
(IRB No. H-1510-097-712), and Yangsan Pusan National University Hospital
(IRB No. 04-2015-038). All participants provided written informed
consent to participate in the study.