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Because the final inflated average case-weighted standardized charge per case exceeded the average case-weighted threshold amount in both analyses, the applicant asserted that the DETOUR System meets the cost criterion

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Ethics declarations Ethics approval and consent to participate The ReCePI study (CLI 00125 v8.0) has been approved by the WCG IRB, most recently on 23 May 2023 (IRB Tracking Number: 20181561) and by multiple institutional review boards