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Men in the enzalutamide group also had better clinical progression-free survival (PFS), which the research team defined as the time until the return of disease-related symptoms, the detection of new metastases on imaging scans, or the initiation of another cancer treatment for prostate cancer, whichever came first

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The Warning Letter describes a broader operating-model failure: valid cases were rejected or invalidated based on flawed procedural logic, vendor-executed intake was not adequately controlled, medical review timelines were not enforced, and corrective actions were closed without demonstrating that compliance had actually been restored