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Patient selection and subgroup analyses Participation in this nested substudy of SUSTAIN CSX was optional for the sites and within the framework of the existing ethical approval [14]

To clarify how integrated safety data operates in practice, the following areas are addressed: Clinical safety monitoring during development Pharmacovigilance Adverse Event Assessment Post-approval safety oversight and signal detection Regulatory documentation and data traceability Clinical Safety Monitoring During Drug Development Clinical teams monitor safety data continuously during trials to detect emerging risks early

Useful for comparing chemically plausible adducts with microsomal or hepatocyte findings

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