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Adverse event terminology standardization was achieved through implementation of the Medical Dictionary for Regulatory Activities (MedDRA), which employs a five-tier hierarchical classification system: System Organ Class (SOC), High-Level Group Term (HLGT), High-Level Term (HLT), Preferred Term (PT), and Lower-Level Term (LLT)

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Results: Fifteen cases from jurisdictions in Australia, New Zealand, Canada, the United Kingdom and the United States of America met inclusion criteria

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