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10.1002/1097-0142(196203/04)15:2 3.0.CO;2-5

Following a pre-IND meeting, the FDA raised no concerns on the preclinical package, confirmed that current data would support activation of US clinical sites if an IND is submitted, and considered the Phase IIa design appropriate for this development stage

I prefer adjustable models because you can fine tune and choose a more conservative cutoff, such as 12.0v or 12.2v, instead of being stuck with a lower fixed cutoff

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