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In cases with more than two measurements, the last score within 365 days was used (see Section C in Multimedia Appendix 1). Prediction modeling was based on validated Dutch OQ-45 cutoff scores to assess a clinically relevant decrease in symptoms between two measurements (reliable change index: a decrease of at least 14 points in total score) [45,47].
J Particip Med 2025;17:e67170
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The Guidance of Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C mentions referencing 21 CFR 820.100(a)(2), which requires procedures for implementing corrections or preventive actions to include an investigation of the causes for nonconformities related to the product, processes, and quality systems.
JMIR Med Inform 2025;13:e67552
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