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A parametric study was undertaken to determine: (i) suitable TE-modules for this application, (ii) the optimal spreading of the TE-heat pumps, and (iii) the composition of the double glazing unit.
A two-staged Simon accrual design was adopted for this phase II trial.
An 'optimal two-stage design' was chosen for this phase II trial (Gehan, 1961).
A two-stage Simon accrual design was adopted for this phase II trial [ 19].
The trial registration numbers for this phase II study are NCT01124435 (ClinicalTrials.gov Identifier) and 935/03 (study ID numbers).
The Simon's two-stage optimal design was used for determining the total number of patients required for this phase II study.
In the event there is significant site-to-site variability in the estimated effect, stratified results will be reported for this phase II study.
Simon's two-stage minimax design was used to determine the sample size and decision criteria for this phase II trial (Simon, 1989).
The rationale, at least in part, for this phase II study comes from pre-clinical data suggesting MTX and LV potentiate the anti-tumor activity of 5-FU.
Taking into account a 50%% prevalence of CC without RAS mutation, accrual of 165 patients is needed for this Phase II trial.
The previous benefit of a continuous low dose infusion of 5-FU combined with increased drug accumulation in tumour tissue provided the rationale for this phase II trial.
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