36
Accountability of Subject Cohort
A total of 173 subjects consented and enrolled at 20 investigational sites. Of the 141 subjects
completing the baseline evaluation, 121 underwent an evaluation using an SCS trial system with
tonic stimulation. After the SCS trial evaluation, 101 subjects met the standard criteria for success
and were implanted with the Prodigy™ neurostimulation system. Of these 101 subjects, 100 were
randomized and activated. The final subject was randomized in August 2015. A total of 96
subjects completed the week-24 follow-up visit for the primary endpoint. The following figure
summarizes the accounting for study subjects.
Figure 9. Subject accounting