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The new results are from a Phase III trial, typically the last stage before approval.
Fig. 9 Kaplan Meier survival analyses for phase III trial.
In the phase III trial, 4532 newborns received ROTAVAC.
But again, in a phase III trial with unselected patients, tirapazamine did not improve outcome [36].
After successful Phase II clinical trial, a Phase III trial for AML has started in 2008.
It was associated with survival benefit in a phase III trial in severe sepsis [5].
These results are not sufficient to start a phase III trial.
This article describes the study design and indications for enrollment in the phase III trial.
Definitive evaluation of efficacy in a larger phase III trial is warranted.
Twenty-three responses among 37 patients were considered necessary to proceed to a phase III trial.
Business obstacles threaten to delay the phase III trial of a copper-depleting drug.
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CEO of Professional Science Editing for Scientists @ prosciediting.com