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7 Recently, a higher dose of donepezil (23 mg/day) was approved by the FDA for the treatment of moderate to severe AD based on outcomes from a large multinational, doubleblind trial comparing donepezil 23 mg/day with donepezil 10 mg/day.
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Combination therapies may provide a reasonable solution, but multicenter, randomized, doubleblind trials are still lacking, particularly in elderly anemic patients with heart failure.
Multinational trials that had trial sites in India and South Africa were selected for this study.
But his triumph was met with skepticism until a multinational clinical trial confirmed his results.
It provides a standardized, consensus-driven approach that enhances the rigor of LV for PRO measures and advances measurement science in a multinational clinical trial environment.
The approval was based on phase III multinational, randomized trial METRIC [ 56, 57].
At this point a phase III multinational clinical trial is ongoing.
A similar multinational trauma trial is nearing completion outside the USA.
Phase III, double-blind, placebo-controlled, multinational AFFIRM trial in men with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel.
The MORE study was a randomized, placebo-controlled, multinational clinical trial designed to evaluate the efficacy and safety of raloxifene.
In brief, it was a multinational randomized trial with a 2 × 2 factorial design that tested two pairs of interventions.
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