Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity").
CONCLUSION These findings demonstrate the safe and efficacious use of a novel intramedullary fixation device for fibula fractures with lower wound complications compared with published outcomes found with lateral fibular plating.
Several chemo-triplet schedules with 5FU/LV or capecitabine, irinotecan and oxaliplatin were evaluated with the Italian FOLFOXIRI demonstrating the most efficacious and reliable data [ 37, 43- 46].
Although these issues likely will not be settled unequivocally, recent epidemiological studies have shown that anxiety disorders among alcoholics often are independent (e.g., Grant et al. 2004; Williams et al. 2010) and clinical studies have demonstrated that efficacious treatment of one disorder does not necessarily yield improvements in the untreated comorbid disorder (e.g., Thomas et al. 2008).
The objective remains to demonstrate that the new treatment is efficacious in the trial for all treatment-experienced subjects with a statistical significance at a level of 0.05.
Should there be no ethic concerns, the objective was to demonstrate that the new treatment is efficacious in the treatment-experienced population at a level of 0.05, with no need to show statistical significance in each of the two strata at level of 0.05.
This dose had been previously demonstrated as efficacious.
This trial contributes to other RCT data demonstrating that efficacious treatment of moderate to severe psoriasis results in improvements in HRQOL [ 7- 9, 37, 38].
The objective is to (1) demonstrate that the new treatment is efficacious in the trial for partial responders, and responder relapsers with a statistical significance at a level of 0.05; and (2) demonstrate that the new treatment is efficacious in the trial for null responders with a statistical significance at a level of 0.05.
An MA is granted if the applicant can demonstrate that the drug is safe, efficacious, and of suitable quality.
