Exact(12)
In the new study, the winners of this drug competition will be tested in a definitive Phase 3 study with just 300 patients whose tumors have a similar genetic profile to those of the women who responded.
If the interim outcome is more positive, the trial continues to an originally planned larger sample size for a definitive Phase 3 evaluation.
In the Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST), we aimed to assess the efficacy and safety of tenecteplase versus alteplase within 4·5 h of stroke onset in a population not selected on the basis of advanced neuroimaging, and to use imaging biomarkers to inform the design of a definitive phase 3 clinical trial.
The impressive clinical phase II results involving these criteria have led to a definitive phase III study [ 4].
In addition we wanted to obtain data to inform a definitive (phase III) cluster randomised controlled trial (RCT).
The impressive phase II results with the PARP inhibitors have led to a definitive phase III study involving more than 420 patients that will be finished in 2010.
Similar(48)
However, due to possible differences in the composition of our standard minerals and those in the meteorites, we do not attempt to perform any definitive phase identification.
The aim was to select the 'preferable' preoperative chemotherapy arm for a future definitive phase III trial, with the DFS rate at 1 year as primary end point.
In addition to providing important information on the safety and efficacy of ASA in patients at high risk for ALI, the results of this trial will also inform the scientific community regarding the merit and feasibility of a more definitive phase III clinical trial.
In addition to providing important information on the safety and efficacy of the use of esophageal pressure in managing ventilation in patients with moderate-to-severe ARDS, the results of this clinical trial will also inform the scientific community regarding the merit and feasibility of a more definitive phase III clinical trial.
In phase II, embarking on a preliminary evaluation, was, we feel, more cost-effective than attempting a definitive stage III randomised controlled trial.
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