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This study was declared to Clinicaltrial.gov.
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).
This study was declared exempt by the Institutional Review Board at the University of Michigan.
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The intake data presented in this study were declared by the participants or by a parent in the case of children.
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 protocol was reviewed by the Committee for the Protection of Human Subjects in Biomedical Research of St Antoine University Hospital and the data file of the study was declared to and authorized by the French data protection committee (Commission Nationale Informatique et Liberté).
The protocol has received the agreement of the Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale (Centre Régional de Lutte Contre le Cancer Léon Bérard, Lyon (France) and the study was declared to the Commission Nationale de l'Informatique et des Libertés.
This investigator-initiated study was declared at www.ClinicalTrials.gov (EudraCT number 2006-000925-71) and complied with the principles of the Declaration of Helsinki.
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 the French Health competent authority (AFSSAPS) and registered under the reference number 2004/12/013.
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