Pharmacovigilance medical writers and safety physicians at pharmaceutical companies use this agent when drafting the Integrated Benefit-Risk Evaluation section and Signal Evaluation appendix of a Periodic Safety Update Report (PSUR/PBRER) for EMA or a Periodic Benefit-Risk Evaluation Report for FDA, synthesising cumulative post-marketing safety data into a benefit-risk conclusion that satisfies both ICH E2C(R2) and EMA variation triggers.