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Besides the original Braak staging, the study design allowed a direct correlation between the biochemical findings and the amount of neurofibrillary tangles (NFT) and neuritic plaques, quantified in adjacent tissue sections.
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The perceived ethical challenges and issues raised by the ethics review committees were addressed in the ethical approval stage, in the study design, in the planning stage and also during the conduction of the study in the actual field setting.
In the optimization stage of the study Design of Experiment (DoE) is used to identify critical variables of the system by fitting a polynomial to the experimental data in a multiple linear regression analysis.
JC was involved in the initial stages of the study design and in revising the manuscript.
All authors were involved in various stages of the study design.
Thanks also to Dr. Paul Seed, Dr. Peter Miligan and Dr. Naohiro Yonemoto for their statistical comments at the early stage of the study design.
The research team was multi-disciplinary at all stages, including the study design, data collection, analysis and manuscript writing, with researchers experienced in using qualitative research methods.
A total of 41 patients were prospectively accrued between January 2007 and July 2009; the two stages of the study design were both completed in the absence of excessive toxicity or unacceptably poor outcome and all patients were evaluable for toxicity and response.
These companies had no involvement at any stage of the study design, in the collection and analysis of data, in writing the manuscript, or in the decision to submit for publication.
Importantly, the distillation of the gene list into compact model (CDM) introduces an opportunity to catch a glimpse at possibly causative mechanistic alternatives that otherwise would took years to uncover through hypothesis-driven experimental studies that tend to look after overall plausibility of possible findings at the stage of the study design.
Therefore, cooperation with statisticians is important already at the planning stage with identification of the study design and the preparation of the written study protocol.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com