Once the DSMB saw the fluky mush in their interim look at RD2, I believe that they would have taken a look at RD1 to see if the same thing was happening. If it was, I would expect that they would have told Cortex to add patients to make up for some proportion of the unusable data, as they did with RD2. I have heard nothing to make me think that was done.
I believe the likelihood of the misfit masks and of anxiety reactions in RD1 is less than in RD2, because of the experience the RD1 investigators have with respiratory trials. They make their living, academically speaking, from researching respiration and factors affecting it. If they hadnt learned how to do that with reliability (reproducible results), they wouldnt have had anything to publish, all would have been mush.
So I don't think they had to alter the procedure. That doesn't necessarily mean RD1 worked at 1500mg, but I doubt that they have uninterpretable mush.
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