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To gather information for a future confirmatory trial of dobutamine (DB) for circulatory impairment (ie, low superior vena cava [SVC] flow).
This design was implemented in a recently completed clinical trial of simtuzumab (RAINIER study) and provides a useful case study for designing future confirmatory clinical trials of novel targeted therapies.
Finally, to help present-day design studies and in the expectation of future confirmatory R&D results, recommendations are provided on SiCf/SiC parameters and properties to be assumed for present design analysis of long term SiCf/SiC-based power plants.
The purpose of the secondary outcomes was to gain further insight into the efficacy of the vaccine and to help define a primary endpoint for a future, confirmatory Phase III trial.
This was a secondary data analysis, and all findings warrant replication in future confirmatory research.
Therefore the findings from this study have implications that are relevant globally and would benefit from future confirmatory evaluations.
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Future prospective confirmatory studies are needed to validate our results and examine the exact underlying mechanism by which vitamin D levels may impair pregnancy rates in infertile women undergoing IVF/ICSI.
In future quantitative confirmatory studies, simple measurements assessing relaxation, stress, quality of life and well-being could be used and a routine therapy group or another active treatment group such as therapeutic touch or empathic listening could be used as a comparison.
However, it will be important for future studies utilizing confirmatory factor analysis to address this issue and directly compare fits between the two- and three-factor solutions.
A better designed protocol, including a solid statistical analysis plan, has been proposed to be included in a future study to provide confirmatory evidence on the use of ultrasound in such a clinical setting.
This study obtained estimates of the incidence and prevalence of septic shock and/or death in septic neonates for future sample size calculations for confirmatory studies and evaluated the feasibility of using sTREM-1 as a predictor of septic shock and/or death in neonates with LONS criteria.
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