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The U.K. antismoking app txt2stop showed some benefit in a randomized study of 5524 participants.
As an adjunctive treatment in sepsis, patients administered high-dose (0.9g/kg body weight) intravenous immunoglobulin G (IvIgG) did not have a significant survival benefit in a randomized control study (The SBITS study) (1).
○ Radiopharmaceuticals: None of the currently FDA-approved radiopharmaceuticals (eg, Sr, Sm) have demonstrated an OS benefit in a randomized Phase III study in men with mCRPC.
It is the first drug approved for the treatment of melanoma by the FDA which has shown a survival benefit in a randomized Phase III study.
Central to this paradigm is the selection of a single primary predictive biomarker clinical benefit ID hypothesis that will be subjected to statistical validation as a predictor of clinical benefit in a randomized phase 2 PoC study.
It is the first drug approved for the treatment of melanoma by the Food and Drug Administration FDAA) which has shown a survival benefit in a randomized Phase III clinical trial.
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Nevertheless, such innovations should be required to meet the standard of proof-of-benefit in a randomized prospective clinical trial before being introduced into widespread clinical practice.
Hypnosis, acupuncture and peppermint oil have shown considerable benefit in a few randomized controlled trials for IBS [ 22, 23] but are used by relatively few patients.
For patients with FLT3-ITD mutations, the addition of the FLT3 inhibitor CEP-701 to chemotherapy at relapse did not result in any survival benefit in a recent randomized study.
The small number of controlled studies that were performed failed to demonstrate a significant benefit – with the exception of cyclophosphamide, which showed a modest, statistically significant benefit in a recent randomized controlled trial [ 5], and to a limited extent methotrexate for early active disease [ 6].
Significant positive health benefits came in a randomized controlled clinical trial that used this approach for three months and lowered the biomarker value from 77% to 61% n-6 in HUFA [ 65].
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