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Drugs with unknown clinical patient benefit or statistical significance of efficacy (data unavailable or insufficient).
Because of power considerations and the fact that safety of low dialysate [Na+] was demonstrated in the pilot study, no interim analyses are planned and no stopping rule based on statistical significance of efficacy data, frequentist or Bayesian, has been set.
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Although variability of the efficacy data was notable and the study was not powered to evaluate the statistical significance of the efficacy measures, reported and observed pain-related treatment effects seemed apparent for AMG 403 with sustained response beyond the final dose.
Statistical analysis to assess the significance of treatment efficacy results on bacterial numbers remaining after drug treatment was performed for mouse models [44] and guinea pig models [23], as described before.
Statistical significance of vaccine efficacy was based on a lower limit of the 95% CI greater than zero.
In conclusion, we have extended the statistical results of Michelson et al. [ 3] by using drug-placebo response curves to describe the clinical significance of the efficacy of atomoxetine in the treatment of ADHD among adults.
Most importantly, Heinen-Kammerer et al. [ 28] added to the calculation the costs of preterm birth and its consequences for up to five years, which favoured fenoterol over atosiban with no justification in statistical significance of differential efficacy.
Cumulative clinical and scientific discoveries, along with regulatory requirements of demonstrating statistical significance for efficacy claims, have resulted in increasingly narrowly defined indications and stratified patient populations in clinical trials.
Similarly to the dalotuzumab/MK-2206 dalotuzumab/MK-2206ce in terms of efficarm of thesignificance unknown based on the lack of data on tumour growth rate before study partinipaterms
The paired t-test was used to determine the statistical significance of differences in efficacy of bee-venom serum.
3) The role and the significance of HRQoL as efficacy, tolerance, utility endpoint [ 10, 11] These points and the reasonable scepticism of regulatory authorities to officially acknowledge some subjective criterion whose clinical meaning remains difficult, have limited the use of PROs in the drugs approval process.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com