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± Neuromodulation Division Peripheral Nerve Stimulation of the Occipital Nerves for Chronic Migraine Clinical Study Results Clinical Study Design Patient Enrolled Group A: Active PNS Implanted 2:1 Ratio Randomize and Device Activation Group B: Control (Blind) 80- to 90-day roll in 4-week visit 12-week visit 24-week visit 52-week visit The integrity of the Control (or blind) group was maintained as: 1/ Both patients in the Control group, and the study investigator were blinded, so nobody knew who was active or control 2/ All Control patients were given programmers that appeared to be functioning, but did not communicate with the IPG (for the first 12 weeks). 3/ Patients in the control group were told that a range of different settings were being tested which was not indicative of whether they were in the control or active group. Confidential. For Internal Use Only. St. Jude Medical Neuromodulation Division.