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CW and PM developed the design and analysis plan of this study and performed statistical analyses.
CMT, PM and SBW developed the design and analysis plan of this study.
AB, SZ, CMT, JH and RL developed the design and analysis plan of this study.
Because the original plan of this study was to evaluate gene expression changes before and after bortezomib treatment, the discovery of predictable biomarker was a big surprise.
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Assuming a non-inferiority design at the planning of this study, the planned sample size in phase III was 364 patients (including phase II patients) with a power of 80%, a one-sided alpha of 5%, an expected 1-year OS of 40%, and a non-inferiority margin of 1.31 for the hazard ratio.
Jui-chien Hsieh, Ph.D. was involved in plan and design of this study.
We describe different design alternatives in the planning of this study, the reasoning for choosing the adaptive design and experiences with conduct and interim analysis.
In the planning of this study, it was postulated that geographic distance from an academic center might be a risk factor for receiving care that was non-adherent to guidelines.
The deceased Professor A. Tarkowski participated actively in the planning of this study and the early writing of this manuscript.
Even before the beginning of the planning of this study, we have been interested in the transcriptional regulation of CDT2 by the E2F transcription factors.
We are indebted to Howard L. Snell for guidance in the planning of this study and for logistical support for the 2004 field collection.
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