Observation items and schedule
The enrolled subjects were observed for 104 weeks in the main study followed by additional 104 weeks in this extension study, totaling 208 weeks. In the main study, clinical and biochemical data were collected at 0, 26, 52, 78, and 104 weeks after randomization, and in this extension study, the data were collected at 156 and 208 weeks after the randomization in the main study.