Anavex Life Sciences Corp (AVXL)

[Doc328]

In Avatar, there were 2 dropouts - both young adult women among the 20 patients who received A273. Zero placebo dropouts in that 7 week trial. US-Adult Rett had zero dropouts among the 15 treated and 10 placebo patients.

Using general consensus - the mITT population would be those girls who completed the 4 week assessment. After that assessment, if a patient drops out they would be handled with MMRM imputation. Per protocol or protocol completer (PP or PC) would be those who did all assessments (presumably 4, 8, 12 week) - we don't know that number. So 15 patients dropped but we don't know how many placebo vs treated but presumably these would have dropped out in the first 4 weeks.

The safety population is always the population that took at least one dose (either drug or placebo) so should be all 92 patients (maybe 90-91 if 1 or two screened but then decided not to do the study)

Placebo affects both treated and untreated, hence why we often subtract one from the other to see what the treatment effect might be.