Pete - depends on how they construct it. They could do 2 arms, P treated and current standard of care treatment or 3 arms - P treatment, standard of care treatment and placebo treatment. As long as they keep it blinded - they can really have leeway in construction. Can be anywhere from 100 patients to more than 1000. We'll see! It will be randomized - but since Prur is not testing cancer - they have a lot more choice in constructing comparison arms. (ie - never placebo arm in cancer trials).
This trial will take a while. One solid year from start to finish would be really fast. Less than that will be miraculous.
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