legend text: Graphical representation of assessed Z and V scores and corresponding boundaries. An evaluation was made after each subject reached an endpoint of recurrence prior to 63 days or non-recurrence at 63 days. Highlighted Z score values of 0.65 and 2.85 represent the third and seventh subject’s endpoint evaluation. Evaluation of the seventh subject crossed the failure threshold and enrolment was halted. Values after that point represent subjects already enrolled when enrolment was terminated.