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A statistically significant improvement in iDFS was observed in the intent-to-treat (ITT) population at an interim analysis. The efficacy results at the time of the final iDFS analysis are summarized in Table 18 and Figure 1. At the time of the iDFS final analysis, OS was immature, and a total of 172 (3.5%) of patients had died across both study arms.
from FDA，2024.09
