Several randomizedplacebo controlled double-blind studies, as mono or combination therapy, have demonstrated treatment efficacy as well as excellent tolerability.
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This large randomizedplacebo-controlled phase III trial evaluated the mTOR inhibitor ridaforolimus to assess maintenance of disease control in advanced sarcomas.
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This approach yielded exciting results in a randomizedplacebo controlled trial in 80 adult patients with T1D.
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Results: The randomizedplacebo-controlled double-blind parallel-arm drug clinical trials should be the design of choice for both phase II and III trials.