2. The 16-week CR rate (primary endpoint)
In modified ITT analyses, the overall CR rate at 16 weeks was 36.4% (48/132). The 16-week CR rates were 25.6% (11/43) in MA group, 45.7% (21/46) in LNG-IUS group and 37.2% (16/43) in MA+LNG-IUS group, without statistical difference among the three groups (P=0.143) (Table 1; Fig.2A). However, LNG-IUS group yielded a higher 16-week CR rate compared with MA group (p=0.049, Odds ratio [OR], 2.44; 95% confidence interval [95%CI], 1.00-6.00). MA+LNG-IUS group did not achieve higher 16-week CR rate compared with MA group or LNG-IUS group (Table 1, Fig 2).