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Re: georgejjl post# 452881

Wednesday, 02/28/2024 2:15:01 AM

Wednesday, February 28, 2024 2:15:01 AM

Post# of 460230
It is a P2 trial that among other things is attempting to establish the appropriate dose. It has 5 arms to it with a total of 40 subjects, there won't be nearly enough subjects in each arm to justify approval or allow reasonable statistics. It has approximately 39 Primary outcomes and 8 secondary outcomes.

This is a P2 trial that will provide the data to design a P3 trial.

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