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Demographics, medical history, physical exam, headache features, and headache treatment history were recorded at the baseline visit (week 0).
The dose and regimen of the oral preventive treatment must have been stable for > 4 weeks before the first intervention visit (week 0, visit 2).
Patients who discontinued topiramate at any time were allowed the option of crossing-over to receive onabotulinumtoxinA at the next scheduled office visit (week 12 up to week 36; Fig. 1).
Each PRO domain and summary score within the maintenance phase sample were analyzed using a MMRM model, with subject as a random effect and with maintenance phase visit (Week 8, Month 12), sustainer status at Month 12 (remission, not in remission), and the visit * sustainer status interaction as fixed effects.
Hematology, biochemistry, and urine analysis were repeated at the final visit (week 16).
Blood for hematology was collected at baseline and at the last patient visit (Week 12).
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Usually we spoke every week on the phone, yet after my visit, weeks passed with no call.
Clinical assessment and laboratory parameters were performed at all visit weeks with the exception of week 1.
The change in the HbA1c from baseline (screening visit week-2) to 24 weeks will be the primary efficacy measure.
At visit week-6, month-4 and year-1 pp, the infant weight and height, head circumference, and waist circumference (only at year-1) were determined in the study center.
HbA1 c measurements were comparable at visit weeks 12, 28, 36 and 52 for the two groups.
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