seems to be the reason why ALSFRS-R is subjective as it’s a matter of perspective. That said, in some respects each patient is their own control as it provides a baseline at each data point.
I imagine there may be a strong placebo effect for progression but ultimately survival stats will prevail, which is why the data matched protract are still relevant. Not a statistician but even if the actual results are only a quarter as good as the OLE it’s a blockbuster.
DYOR
Ann: Positive Interim Study Results from OLE Study in ALS, page-46
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