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Table 1 Patient selection criteria

From: Continuous combined oral contraceptive use versus vitamin E in the treatment of menstrual migraine: rationale and protocol of a randomized controlled trial (WHAT!)

Inclusion criteria

 • Female sex

 • Age ≥ 18 years

 • Menstrually related migraine or pure menstrual migraine (ICHD-3 criteria [25, 27])

 • Demonstrated at least 80% compliance with the E-diary during the baseline period

 • No or stable for at least 2 months on prophylactic medication

Exclusion criteria

 • Migraine with aura with ≥ 50% of their migraine attacks accompanied by auras

 • Chronic migraine (ICHD-3 criteria [27])

 • Medication-overuse headache (ICHD-3 criteria [27])

 • Women who are breastfeeding, pregnant, or planning to become pregnant

 • Hormonal contraceptive use and not willing to undergo a washout period (stop for two consecutive months)

 • Vitamin E use at start of the study

 • Use of other sex hormone-containing treatments

 • Increased risk of venous thromboembolism (VTE): history of VTE or thrombophlebitis, hereditary predisposition for VTE (APC resistance, protein C or S deficiency, antithrombin deficiency), VTE in first-degree family member at young age, long-term immobilization

 • Increased risk of arterial thromboembolism (ATE): history of ATE, hereditary predisposition for ATE (hyperhomocysteinemia, antiphospholipid antibodies), ATE in first-degree family member at young age, diabetes mellitus, total cholesterol ≥ 6.5

 • Other contraindication for combined oral contraceptives: liver malignancy, schistosomiasis, HIV/aids, use of immunosuppressives, tuberculosis, sex-hormone-dependent malignancies (breast, endometrial or ovary carcinomas), pancreatitis, vaginal bleeding with unknown cause, other diseases that can influence vessels (malignancies, heart valve disorders, atrial fibrillation, SLE, hemolytic uremic syndrome, chronic inflammatory bowel disease, sickle cell disease)

 • Contraindication for vitamin E: vitamin K deficiency

 • Hypersensitivity for any of the compounds in the combined oral contraceptive pill or vitamin E

 • Spontaneous postmenopausal status (menstrual bleedings have ceased for 12 consecutive months)

 • Iatrogenic postmenopausal status

 • Inability to complete the E-diary in an accurate manner

 • Any serious illness that can compromise study participation

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ISSN: 1745-6215