Study design
This multi-center, randomized, double-blind, placebo-controlled, parallel group-comparison, phase IIb/III clinical trial, comprising a 2-week wash-out period followed by a 12-week double-blind treatment period, was conducted in 15 medical institutions in Korea between February 18, 2020 and February 8, 2021.The study was approved by the Internal Institutional Review Board (IRB) of respective sites involved in it (2019AS0275) and then conducted in compliance with the relevant ethics guidelines. All the study treatments and procedures described herein were performed in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. All participants provided written informed consent. The current study is registered with ClinicalTrials.gov (registration number: NCT05017844, first posted date: 24/08/2021).