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Furthermore, the FDA guidance encourages planning for clinical trial interpretation using an a priori responder definition.
MJS contributed to the conception and design of the trial, interpretation of the data and writing of the manuscript.
The effect on clinical trial interpretation when using these methods is not necessarily trivial, and has caused substantial debate regarding their usefulness and validity (Senn, 2000).
All authors were involved in the design of the clinical trial, interpretation of the findings and were responsible for drafting and critically revising the report, having full access to study data.
K. K. was the chief independent medical expert for this study, and was involved in the design of the clinical trial, interpretation of the findings and reviewed and approved the final manuscript.
JWSV: involved in conception and design, made contributions in obtaining grants, involved in choosing measurements, development of cognitive-behavioral intervention, participation in trial, interpretation of data and substantial contribution in revising the article for important intellectual content.
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Inconsistency in cardiac event reporting in the major AI trials makes cross-trial interpretation difficult.
In fixed dose trials, interpretation of statistical inference can be done in terms of causal relationship between treatment and an outcome, based on the principle of randomization.
At present, design of clinical trials, interpretation of outcome data and finally clinical managing of mRCC patients are based on predictive models of risk including a series of prognostic factors (time to start of therapy, serum LDH and Calcium levels, anemia and low performance status) (Patil et al, 2011).
When process evaluation has been conducted to interpret trial outcomes, interpretation needs to be clear in the published papers, with process evaluation data linked, in discussion, to trial outcomes.
Individuals meeting diagnostic criteria for body dysmorphic disorder (BDD; N = 40) were enrolled in a randomized, four-session trial comparing interpretation bias modification (IBM) training designed to target social evaluation- and appearance-related interpretation biases with a placebo control training condition (PC).
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