2 ± 6.5 versus 107.2 ± 6.4; p = 0.0411). This translates into a relative decrease in the HFS of 21.5%

in favor of women treated with BRN-01. Furthermore, a clinically relevant decrease of 3 points in the HFS was obtained after 3.2 ± 1.5 weeks #Acadesine purchase randurls[1|1|,|CHEM1|]# in the BRN-01 group versus 3.6 ± 2.5 weeks in the placebo group, although with no inter-group difference (p = 0.3632). The evolution of the HFS over the course of the study is shown in figures 4 and 5. Fig 4 Evolution of hot flash scores over 12 weeks in the BRN-01 and placebo treatment groups. Fig 5 Evolution of hot flash scores over 12 weeks, adjusted for baseline values (at week 1), in the BRN-01 and placebo treatment groups. Secondary Evaluation Criteria After 12 weeks of treatment, the HFRDIS score for QoL was not significantly lower in the BRN-01 group than in the placebo group (2.3 ± 1.9 versus 2.8 ± 2.4, respectively; p = 0.2430). The reduction in the HFRDIS score was significant in each group but did not differ significantly between the two groups (2.3 ± 2.3 [95% CI 1.7, 3.0] for BRN-01 versus 2.0 ± 2.7 [95% CI 1.2, 2.8] for placebo; p = 0.5121). A similar result was obtained for each of the ten dimensions of the HFRDIS score (figure 3). The reduction in the MRS score at

week 12 was also significant for each group but did not differ significantly between the two groups (5.1 ± 5.9 [95% CI 3.1, 7.2] for BRN-01 versus 7.8 ± 9.5 [95% CI 4.7, 10.8] for placebo; p = 0.1774). A similar Caspase Inhibitor VI concentration reduction in distress in the patients’ professional and/or personal life and in the number of night sweats between week 1 and week 12 (as measured using a VAS) was also found (data not shown). ADP ribosylation factor Compliance Calculation of the Morisky-Green score showed that there was poorer compliance with treatment in the placebo group than in the BRN-01 group, although the difference was not statistically significant (figure 6). This was confirmed by the greater number of unused tablets returned by patients in the placebo group (185.5 ± 98.4 for placebo versus 167.0 ± 98.2 for BRN-01; p = 0.3773). Fig 6 Morisky-Green scores

for compliance in the BRN-01 and placebo treatment groups. Safety BRN-01 was well tolerated. There were five AEs in the BRN-01 group and four in the placebo group, including one severe AE in each group. These latter AEs were not considered to be related to the study treatment. There was no statistically significant difference between treatment groups in the number of patients experiencing an AE or a serious AE (p = 0.7409). Details of the AEs are shown in table III. Table III Table III. Adverse events occurring in the two treatment groupsa Discussion This randomized, double-blind, placebo-controlled study was carried out in two groups of menopausal women with similar sociodemographic, clinical, and therapeutic characteristics.