i got a hold of the full note, the next page says something on this. Apparently in these cases a third arm is introduced whcih is another active drug arm. suggests risk from here is trial redesign (increase in costs - more patients). Alternatively you go ahead with the trial as is (if its a legitimate issue) and risk someone seeing the blinding as a major issue or lacking in quality data ie the FDA or potential partners.
i got a hold of the full note, the next page says something on...
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