Pivotal Study Outcome Patient Accounting
Total US Europe
I C I C
Design sample size: 180
#Enrolled (ITT): 281 102 98 41 40
# At second-look (EVL): 265 93 95 38 39
Lost to Follow-up: 9 3 3 1
% At second-look: 91.1% 96.9% 92.7% 97.5%
Data Sets:
ITT: Intent to Treat population
EVL: Evaluable population
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