Top-line results showed that, although there was weight loss in many of the patients, there were no statistically significant differences among any of the treatment arms versus placebo. However, a post hoc segmentation analysis revealed an important finding regarding the effect of age and gender on drug response.

Analysis of the subpopulation consisting of females, aged 50 years or less, in the per protocol (PP) cohort, demonstrated a substantial difference between the mean weight loss in the high dose arm (48 mg/day) versus the placebo arm; the result showed a trend towards statistical significance (p=0.06 at 8 weeks and p=0.146 at 12 weeks).

The effect was even more pronounced when the analysis was limited to non-hispanic - women, 50 years old or younger. At the end of week 12, the 25 women on the 48 mg Histalean(TM) dose had lost an average of 2.61 Kg (2.91%) of their weight, versus 23 women on placebo, who lost only 0.4 Kg (0.43%) of their weight. This result was statistically significant with a p value of 0.003. The effect of ethnicity on drug responsiveness in the current analysis is still inconclusive, since the number of hispanic women in each study group was very small (4-5).