IMO it's likely that data sufficient for a base line is being acquired in the routine care and observation of these girls. These girls are so sick there is little chance of placebo effect, and apparently the FDA concurs.
Reduction in number of seizures in Rett girls will hardly be biased even the first 7 weeks are not placebo controlled. The girls can’t fake it and the parents won’t just ‘feel’ as if their daughter is having fewer seizures. They can be counted and compared to the 7 weeks prior to taking A2-73.
Other measures I’m sure can be much more subjective and influenced by bias.
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