22. Has received any investigational agents within 30 days prior to Visit 1. At visit 2, subjects randomized to group A (SumaRT/Nap) were dispensed 14 tablets, composed of 85 mg of sumatriptan and 500 mg of naproxen
sodium, to treat migraines acutely for a maximum of 14 days during the next month and an additional 14 tablets for treatment of nonresponse to the initial dose or recurrence within 2-24 hours. Two doses of study medication were not allowed within 2 hours of each other. Subjects were allowed to rescue with a medication other than a triptan MI-503 or NSAID between 2 and 24 hours following the first dose at the discretion of the investigator. Subjects were instructed on how to take BIBW2992 cost medication, dosage limitations (ie, not more than 2 tablets per day separated by at least 2 hours and to treat no more than 14 days per month), storage requirements, and to return all used/partially used/unused medication containers at the next office visit. An identical 1-month supply of
14 tablets for treatment and 14 tablets for rescue of study medication was dispensed at visits 3 and
4. Tablets were identical to those supplied to subjects in group B. At visit 2, subjects randomized to group B (naproxen sodium) were dispensed 14 tablets of naproxen sodium 500 mg for acute treatment and 14 tablets for treatment of nonresponse to initial treatment or recurrence of an attack of migraine within 2 to 24 hours of initial dosing. Tablets were identical to those provided 上海皓元 to group A. Subjects were instructed on how to take medication, dosage limitations (ie, not more than 2 tablets per day separated by at least 2 hours and to treat no more than 14 days per month), storage requirements, and to return all used/partially used/unused medication containers at the next office visit. An additional 14-day supply of naproxen sodium 500 mg for acute treatment and 14 tablets for rescue was dispensed at visits 3 and 4. When needed, rescue medication could be taken at the discretion of the investigator for both study groups. All subjects were encouraged, but not required, to treat within 1 hour of migraine headache onset and during mild headache.