Table 1.

Summary of the patients (n = 10) who were not eligible to participate in the long-term follow-up study.

Reason not invited to participate in long-term follow-up study	Therapeutic response during open-label period
Study not initiated at site (n = 1)	Frequency (n = 1)
Non-compliant: would not show up for clinic visits (n = 3)	Frequency (n = 3)
Non-compliant: would not follow site instructions (n = 1)	Frequency (n = 1)
Non-compliant: would not apply stimulation as directed (n = 1)	Non-responder (n = 1)
Did not meet inclusion criteria – did not have microstimulator still implanted (n = 4)	Not evaluable (n = 4)

Therapeutic responses during the open-label period of the Pathway CH-1 study are provided.