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Subject with a history of migraine headache reports a headache while on study headache is an AE Treatment (drug and procedure) of AEs must be recorded on concomitant medications page Adverse Event Narrative Subject 99-045 (Initials ABC) comes in at the day 14 visit (6-Jun-2005), and reports a migraine on 31-May-2005 lasting an entire day (24 hours)