English to German Medical Mathematics & Statistics Studie zu Knieprothese

The full analysis set (FAS) will include all patients in whom [impLant product] is implanted who have at least one post-baseline performance evaluation.
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The per protocol set (PPS) will include all patients who complete the study and who do not violate the protocol in any way liable to influence the performance outcome. It will also include patients who have a surgical re-intervention or serious adverse event associated with the investigational product prior to study discontinuation. Performance analyses will be conducted for both the FAS and the PPS.