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However, it is crucial to note that comprehensive human safety data remains limited, as most research has been conducted in animal models, primarily rodents

( (2) File Format for EHR Data, Zero Denominator Declarations, and Case Threshold Exemptions (a) File Format for EHR Data Data can be collected in EHRs and health information technology systems using standardized formats to promote consistent representation, interpretation, and allowance for systems to compute data without needing human interpretation