What this means is that clinical trial sites that didn't have access to reasonable basic medical care where part of Ph2b because they needed patients. That led to an anomaly of the sickest of sick were randomized to the low dose group. Now that Voc is proven, sick patients will still be admitted but not from sites that can't provide basic medical care, thus eliminating SAEs that shouldn't have been relevant in Ph2b...hope that helps.
In summary, patients that were too sick for a clinical trial will not be allowed this time around.
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