Table 3.
Schedule of follow-up
| Procedures | Baseline (T0)* | Follow-up schedule | |||
| T0+3 months | T0+6 months | T0+12 months and annually thereafter | |||
| Signed consent form | X | ||||
| Assessment of eligibility criteria | X | ||||
| Contact details | X | ||||
| Review of medical history including: | X | ||||
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| Further investigation (EEG/CT/MRI) | (X) | ||||
| Allocation of study treatment | X | ||||
| Issue of questionnaires in person or by post | X | X | X | X | |
| Review of seizure occurrence and hospital admissions | X | X | X | ||
| Review of AED use (study treatment and concomitant): | |||||
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X | X | X | ||
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| Assessment of adverse reactions | (X) | (X) | (X) | ||
| Resource use | X | X | X | ||
| Reissue of questionnaire by post or at site to non-responders typically 3 weeks later | (X) | (X) | (X) | (X) | |
| Telephone follow-up of questionnaire non-responders typically 3 weeks later | (X) | (X) | (X) | (X) | |
| Special assay or procedure consent and obtain saliva or blood sample for later DNA analysis | Consent and obtain saliva or blood sample for later DNA analysis | (X) | |||
(X)—as indicated/appropriate.
EEG = Electroencephalogram
*At baseline, all procedures should be done before study intervention.
AED, antiepileptic drug.