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Upon closure of the study, the database was transferred to Cyberonics, where data analysis was conducted by one of the coauthor (P. Raman, employee of Cyberonics).
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Time zero (T0) measurements were taken immediately after induction of the double-hit injury and upon closure of the abdomen.
We also relocated the project to the University of North Carolina upon closure of the Mouse Genetics Program at ORNL (Threadgill et al. 2011).
Upon closure of the isolation membranes, autophagosomes are formed within which the cargo is isolated from the rest of the cytoplasm.
Information from all cases is used, including cases whose follow-up ends due to closure of the study, and those lost to follow-up before closure.
Severe difficulties with recruitment were encountered, leading to premature closure of the study.
At closure of the study, dead or alive status was recorded for all patients.
The next two patients showed DLTs (grade 3), which led to premature closure of the study.
All investigators remained blind to this schedule until closure of the study.
With these doses, activity appeared no better than expected, which prompted early closure of the study.
All data will be held for 15 years after closure of the study.
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