128 Chapter 6 STUDY PERIOD Enrolment Allocation Post-allocation Close-out TIMEPOINT month 1 0 month 2 month 3 month 4 > month 4 ENROLMENT: Eligibility screen X Informed consent X Allocation X INTERVENTIONS: Microgynon 30 Vitamin E ASSESSMENTS: Baseline characteristics X Daily E-headache diary (MMD, MHD) Stanford Expectations of Treatment Scale X HADS and CES-D questionnaires X X Headache Impact Test (HIT-6) X X MSQ questionnaire X X PGI-S and PGI-I scales X X Perceived Stress Scale (PSS) X X Adverse event monitoring Figure 2. SPIRIT figure for the schedule of enrolment, interventions, and assessments.
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