129 Rationale and protocol of the WHAT! Trial 6 verifies for each day whether criteria for headache and migraine are met.24-26 Secondary efficacy endpoints are defined as the mean change from baseline to the 12-week timepoint and include the number of monthly headache days (MHD), migraine attacks and the amount of 50% responders, defined as patients who had ≥50% reduction in the number of migraine days. Secondary safety endpoints are the occurrence of adverse events and serious adverse events. Finally, exploratory endpoints are defined as the mean change from baseline in a 28-day period as assessed at the 12-week timepoint (week 9-12). The prespecified exploratory endpoints for this trial are: 1) the amount of 75% responders, defined as patients who had ≥75% reduction in the number of migraine days; 2) the amount of complete responders, defined as patients who had 100% reduction in the number of migraine days; 3) total migraine hours; 4) acute medication treatment days; 5) migraine severity; 6) migraine-related symptom severity; 7) number needed to treat (NNT); 8) number needed to harm (NNH); 9) Migraine-Specific Quality of life questionnaire (MSQ); 10) Headache Impact Test (HIT-6); 11) Patient Global Impressions scales (PGI-S and PGI-I) and; 12) Perceived Stress Scale (PSS) (Figure 2). Characteristics of participants Female participants aged 18 or older with a diagnosis of menstrual migraine, who do not use hormonal supplementation and have had no changes to their prophylactic medication for at least two months, are eligible for this study (Table 1, Table 2). If participants are already using hormonal contraceptives, they should be willing to undergo a washout period of two consecutive months. Subjects will be recruited from our previous WHAT!-diary cohort (P18.181), the Headache clinic at the Leiden Headache Center (LHC), and through national advertising and our dedicated websites (www.whatstudy.nl/en and www.hoofdpijnonderzoek.nl). At our Headache Center, we employ electronic tools in the screening process for our patients. This approach is particularly important as we have previously demonstrated the limited accuracy of self-reported menstrual migraine diagnosis.25 Recognizing the necessity of a prospective headache E-diary for a reliable menstrual migraine diagnosis, we mandate that all patients participating in research studies or receiving clinical care at the Leiden Headache Center complete these electronic diaries.
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