Outpatients, male or female, of any race, between 18 and 65 years of age Female subjects who were pregnant, breast feeding, or planning to become pregnant during the time frame of the study Statistical Analysis.— Statistical analyses were performed using SAS version 9 (SAS Institute Inc., Cary, NC, USA). Sample size was estimated based on a 35% difference in the proportion of all subjects achieving treatment response by Visit 4 (regardless of treatment group assigned) with positive

treatment response being defined as a +2 change in Physician Global Assessment (alpha = 0.05, 80% power). Physician Global Assessment, Response to Treatment: The Investigator will assess response to treatment using the following 9-point scale: +4 Clearance of signs and symptoms (about 100% improvement). +3 Marked improvement (about 75% improvement). Opaganib mouse +2 Moderate improvement (about 50% improvement). +1 Slight improvement (about 25% improvement). 0 Unchanged. 1 Slight worsening (about 25% worse). 2 Moderate worsening (about 50% worse). 3 Marked worsening (about 75% worse). 4 Very marked worsening (about 100% worse). The Physician Global Assessment was calculated for each subject at weeks 4 and 12 (see Table 4). Demographic data were analyzed using two-sided chi-square test or Fisher exact test. Physician Global

Assessment and MIQ were analyzed using the Wilcoxon signed Navitoclax nmr rank test. Changes from baseline in headache diaries or MIQ scores were analyzed using ANCOVA/rank ANCOVA based on baseline variability. Paired t-test/Wilcoxon signed rank test was used to assess the within group tests for the MIQ. The study funder generated the random allocation sequence. A sealed card marked with the subject’s study number was delivered via FedEx to the Midwestern study site. A research coordinator, not involved with the study, would open the card, note the treatment assignment, dilute the compound, fill the syringe, and hand the medication to the study coordinator who assisted the investigator medchemexpress with the injections. Both the study coordinator and the physician were blinded to the treatment allocation number until the completion

of week 12, the end of the blinded study. Demographics.— There were 59 subjects enrolled (first patient in on 9-2-04 and last patient out on 8-8-06) and were randomized into 2 groups: (Group 1) 30 received topiramate plus placebo injections and (Group 2) 29 received onabotulinumtoxinA injections plus placebo tablets. The mean age was 39.6 years with a range of 19.6 to 64.0; 91.5% were women (54/59). Racially, 94.9% (56/59) were Caucasian. At baseline every subject reported at least one problem with a body system (58/59, neurological; 39/59, psychiatric). A physical/neurological abnormality was found in 13.6% (8/59). The median number of years that subjects suffered with migraine was 16. There were 16 subjects (27%) who identified themselves as smokers: 9 in the Topiramate Group smoked 9.