Friday, February 29, 2008 12:08:33 AM
Agreed that if they based their powering model on the ph iib then a lack of placebo effect is probably taken into account. But note that if the "Evaluable patients" didn't include those who came off protocol then a powering analysis based on the 'evaluable patients' would actually be optimistic.
The most powerful thing going for this trial that is clear from the data WE have is that it is that the drug clearly stops menses - and it seems improbable that that wouldn't have a significant effect on anemia.
PS Does anyone know the ITT population per arm in the phase iib Uterine Fibroids trial - in particular the placebo arm?
Clark
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