Randomization methodology
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Randomization will be performed after the pre-phase treatment, stratified by ECOG performance score (ECOG 0/1 vs. ECOG ≥ 2), in blocks with randomly varying block sizes in a ratio of 1:1. The block lengths will be documented separately and will not be disclosed to the centers. Stratification by study center will not be performed due to a large number of centers with presumably few patients. The randomization lists will be provided by the trial biometrician and uploaded into secuTrial® by the data management. The randomization sequence will be produced by validated programs based on the Statistical Analysis System (SAS®).A randomization form will be created in secuTrial®. Performance of randomization will be documented electronically at the study site in secuTrial® to guarantee concealment of the next treatment allocation. Randomization will take place after the pre-phase treatment once the additional randomization criteria are verified.