Study Design

This was a randomized, double-blind, active-controlled, multicenter, phase 3 study conducted at 41 sites in South Korea between February 2017 and May 2018. The institutional review board at each site reviewed and approved the study protocol and other relevant documents before study initiation. The study was conducted in accordance with the principles of the Declaration of Helsinki, Good Clinical Practice of the International Conference for Harmonisation, and the applicable local laws and regulations. All patients provided written informed consent before any study-related procedures were performed. This study was registered at ClinicalTrials.gov (identifier {"type":"clinical-trial","attrs":{"text":"NCT02985216","term_id":"NCT02985216"}}NCT02985216).