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SigmaPlot will be used to analyse the data in this trial.
All data in this trial will be assessed by SPSS v22.0 (SPSS, Chicago, IL, USA).
The data are saved on a daily basis.The medical data in this trial are to be recorded in eCRFs.
This finding may be related to the fact that the cost data in this trial did not vary by patient within treatment group.
We did not impute missing data but analysed the available data for every research question because we believe that missing data in this trial is unsystematic with respect to the investigated relations.
If promising RFS or OS data in this trial are obtained, then a prospective randomised trial will be warranted to compare adjuvant chemotherapy with or without single agent long-term administration of S-1 chemotherapy.
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A detailed methodology for the data management in this trial is documented in a data management plan that is dated and maintained by IZKS Mainz.
The extensive QoL data collected in this trial represents a unique source of information valuing health at every point of time.
There was a minimal amount of avoidable QoL data missing in this trial due to administrative or logistical reasons (approximately 6.5%, shown as missing CLAS data in Table 1).
Our goal was to use data obtained in this trial to feed into probabilistic models (similar to those used in "reliability engineering") which would allow us to find and assess possible ways of improving the interaction between the automated tool and its human user.
In summary, all safety data generated in this trial show that both formulations of the RTS,S/AS candidate vaccine have a favorable safety profile.
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