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Thursday, October 23, 2014 6:14:00 PM
Can anyone help me to understand this:
,...when observed 2-3 days only,...?
Does that mean we do not know if we are equivalent at 28 days,..? -cabel
Here it is on the trial outline:
Primary Outcome Measures:
Early clinical response [ Time Frame: 48-72 hours after first dose of study drug ] [ Designated as safety issue: No ]
The primary efficacy outcome, early clinical response 48-72 hours after the first dose of study drug, will be determined in the ITT population. A subject will be considered a Clinical Success if 1) the lesion area has decreased by =20% compared to baseline and 2) no additional systemic antibacterials that are potentially effective against gram positive organisms have been administered. - Link
We have yet to hear on Secondary Outcome Measures, or the P-Value for statistical significance, or the specific numbers as noretreat pointed out.
PR was definitely a bit rushed.
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