4.9 Exclusion criteria: pregnancy and lactation, pre-medication within six hours of being enrolled in the study, more than six prior headaches per month, allergy to the study drugs, non-migraine headache, substance abuse, alcohol abuse, diabetes mellitus, or a coexisting condition that might expose the patients to a disproportionately increased risk of a significant adverse event: ischaemic heart disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension (blood pressure >160/95), epilepsy, use of cimetidine, dopamine agonist, cyclopsorin, or oral hypoglycemic agents, hepatic or renal failure, and thyroid disorder.