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After completion of data entry and if no further corrections are to be made in the database, the access rights are taken away and the database is declared closed and used for statistical analysis.
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The study was approved by the hospital's ethics committee (No. 14-95), and the database was declared to the Commission Nationale de l' Informatique et des Libertés (No. 8274120).
The database was declared to the National Commission on Informatics and Liberty Commission Nationale Informatiqueetet Libertés N° 1383369).
The database was declared to the Commission National Informatique et Libertés (CNIL NO 3X 02254258) following French law requirements.
All the data were strictly anonymous data, the database was declared to the French authorities "Commission Informatique et Liberté", in accordance with the French law on information processing, The characteristics of the included populations are given in Table 1.
This was an observational study in which informed consent was obtained from all subjects, and the database was declared to the French regulatory agency for computer data (Commission Nationale de l'Informatique et des Libertés, n° 1391593 v0).
In accordance with French law, the OUTCOMEREA database was declared to the Commission Nationale de l'Informatique et des Libertés.
The study and its database were declared safe and were approved by the French authorities (Commission Nationale de l'Informatique et des Libertés) on 7 February 2007.
The research assistant will deliver letter A or B to the statistician after the database is closed and declare the real meaning of the letter A or B when all of the analysis of the data is completed.
The database has been declared to the CNIL Commission National dee l'Informatique et des Libertés".
The study protocol has been approved by the ethics committee of our hospital named 'Comité d'Evaluation de l'Ethique des projets de Recherche Biomédicale (CEERB) Paris Nord.' The database has been declared to the Commission Nationale de l'Informatique et des Libertés (CNIL).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com