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The primary endpoint of the study was declared as "combined adverse outcome" in which this was defined as the occurrence of any delayed complication after initially uneventful postoperative course in patients undergoing elective cardiac surgery.
The study was declared to the French Health competent authority (AFSSAPS) and registered under the reference number 2004/12/013.
The study was declared exempt from review by the Institutional Review Board of the Duke University Medical Center.
The study was declared exempt by the Office of Human Research Administration at the Harvard School of Public Health.
The study was declared to, and approved by the French National Commission for Data Processing and Civil Liberties (authorization number 05-1059 ontained on 24 February 2005).
The study was declared to, and approved by, the National Commission for Data Processing and Civil Liberties (authorization n° 05-1059 ontained on 24 February 2005).
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The study were declared to and approved by the National Institute of Medical Research and Statistics (INSERM).
The intake data presented in this study were declared by the participants or by a parent in the case of children.
This study was declared exempt by the Institutional Review Board at the University of Michigan.
A study was declared negative if the upper bound of the confidence interval was below the threshold of 10 ms, as per ICH E14 guideline [ 1].
This study was declared of public interest by the CNIS ("Conseil National d'Information Statistique") and was approved by the CNIL ("Commission Nationale de l'Informatique et des Libertés", French law number 78-17).
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