RESULTS
Participants A total of 241 subjects were randomized to receive either 20U (stage 1:N=30; stage 2:N=31), 50U (stage 1:N=60), 75U (stage 1: N=61), or 100U (stage 2:N=59) INCO (Table 1). In total, 229 (95.0%) of the 241 randomized subjects completed the study. No subjects discontinued due to AEs or lack of efficacy (Figure 1). All 241 randomized subjects were included in the SES and the FAS.