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A direct efficacy endpoint in GDT studies could be the prevention of fluid overload.
The direct efficacy of the vaccines was considered during the first 5 years of life.
As a randomised phase II study, our protocol was not powered for direct efficacy comparisons between the two arms.
Until direct efficacy and cost effectiveness comparisons are made with risperidone, it is difficult to justify paliperidone use over risperidone.
Furthermore, the FDA guidance for industry on cancer clinical trial design cites symptoms as a direct efficacy endpoint that can be used to support product approval [[ 33]].
Evaluation was performed in accordance with the 'Criteria for the Evaluation of Direct Efficacy in Treatment of Hepatocellular Carcinoma' (Liver Cancer Study Group of Japan, 1994).
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In children <5 estimated as the difference between observed changes in disease incidence from the (ABCs) Report and direct vaccine efficacy from the NCKP trial, assuming all changes in incidence not attributable to vaccine efficacy were attributable to indirect (herd) effects [ 14, 15, 23]; in adults estimated based changes in incidence reported in the ABCs report.
For example, metformin, an anti-diabetic drug that, as mentioned above, has also shown direct clinical efficacy in cancer [243, 244], is an AMPK activator.
This shows that the essential anti-inflammatory sequence (KPV) is also essential for its direct antimicrobial efficacy.
On the one hand, direct antitumor efficacy of DEX has been described in preclinical (Kroon et al. 2015) and clinical studies (Venkitaraman et al. 2008).
Len exhibits direct antitumor efficacy and modulates the tumor environment, especially the immune environment, but the mechanisms of resistance to Len remain partially unknown.
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