Statistical methods
ADVERSE EVENTS
The study was based on Simon's two-stage minimax design. The clinical assumption was that a pCR frequency ≥ 50% was interesting for further studies, whereas a frequency ≤ 30% was of no clinical relevance. With a significance level of 5% and a power of 80%, 19 patients should be enrolled in each arm in the first part of the study. If < 6 patients in arm B achieved pCR, the study would be terminated. Otherwise, enrollment would continue to a total of 39 patients in each arm. If > 16 of the patients in arm B achieved pCR, the treatment with delta-tocotrienol would be interesting for further studies. Thus, a total of 78 evaluable patients should be enrolled in the study. Balanced diagnostics for baseline covariates were estimated using standardized differencesData on delta-tocotrienol treatment were analysed as intention-to-treat according to pathological response and adverse events (grade 3–4). They were presented as contingency tables with frequencies and proportions and calculated as two-sided 