A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants with Drug-resistant Epilepsy with Partial-onset Seizures previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice with or without Adjunctive Vagus Nerve Stimulation Therapy.

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During screening (Visit 1), inclusion/exclusion criteria will be assessed and both the Investigator and participant will sign and date the informed consent. Each enrolled participant will receive 3 months of daily seizure diaries, which will be used to collect seizure frequency information prior to Visit 2.

Visit 2 will take place at least 3 months after the screening visit and only after 3 consecutive months of seizure diary data have been obtained.

Visits 3, 4 and 5 will take place 3, 4 and 5 years, respectively after the randomization date in original PuLsE study, where applicable. If the time period between Visit 2 and the next scheduled follow-up visit (3 or 4 years after original randomization date) is less than 6 months, these visits may coincide.

Participants who took part in the original PuLsE study and who have baseline data will be contacted by the Investigator to request participation in the follow-up study (PuLsE2). The randomization date in the original PuLsE study will serve as the start of the baseline period for this follow-up study; therefore, baseline data obtained in the original PuLsE study will also serve as baseline for the PuLsE2 study.

This study will have a maximum of 5 visits including a screening visit and 3-4 follow-up visits depending on the original randomization date:

1. Screening (Visit 1): Prospective participants will sign an informed consent and will be screened for inclusion/exclusion criteria. Each participant that meets all inclusion criteria and none of the exclusion criteria will continue with a current evaluation of seizure frequency. Participants will be given daily seizure diaries to complete for the 3 consecutive months prior to Visit 2 to document their seizures and any medication changes. Participants will bring completed seizure diaries to all follow-up visits;

2. Follow-up visits (Visits 2-5): Three months prior to each participant’s follow-up visit, the study site will contact the participant as a courtesy to remind the participant to begin completing their daily seizure diary. Each participant will return for follow-up visits at the following time points (as applicable based on the original randomization date): 3 months after the PuLsE2 screening visit, and 3, 4, and 5 years (+/- 3 months) after original randomization date. Depending on the original randomization date, participants may only qualify for 4 and 5 year follow-up visits. Seizure frequency, health outcomes, VNS Therapy programming, concomitant medications, and adverse events will be evaluated at each follow-up visit. The study termination visit will also include neurological and physical examinations.



If Visit 2 (3 months after PuLsE2 screening visit) occurs within 6 months (before or after) of the next scheduled follow-up visit (3 or 4 years after randomization in PuLsE), these visits may coincide.