The qualitative study sample will be a subset of the outcomes sample.
However, the qualitative data sample is expected to be a subset of the outcomes sample.
The fourth study will be a prospective cohort study of the changes in outcomes from baseline to one year for all patients in the outcomes sample.
In addition to the inclusion and exclusion criteria of the outcomes sample subjects will consist of members who joined the study during its first three months.
The inclusion/exclusion criteria for this sample are identical to those used for the outcomes sample with the exception that patients who are currently pregnant will be allowed to participate in this sample.
Methodological items were use of the term "randomised" in the study title and specification of the primary outcome, sample size calculation, method of random sequence generation and allocation concealment, who was blinded, and how blinding was achieved.
Secondary outcomes and hospital process measures will only be collected from the records of patients included in the primary outcome sample, described above.
Differential binding analysis found 1,192 ER-binding events that were stronger in the poor prognosis/metastasis group in comparison with the good outcome samples and found 599 binding events more prevalent in the good outcome tumors.
For the generation of alerts outcome, sample size was sufficient to include all variables in the multivariate model using alternating logistic regression.
These survival curves further show that the classifier in the test sets is unable to discriminate the good prognosis samples that do not overexpress the immune response-module ('good-down') from the poor outcome samples.
