The study was conducted in accordance with Good Clinical Practice, Declaration of Helsinki (V.1996) and applicable local regulations.
The study will be conducted in France and in Belgium in accordance with Good Clinical Practice, Declaration of Helsinki 2002, validated by the ethical committee (Comité de Protection des Personnes - Ile de France IV, IRB n°00003835. Comission d'éthique biomédicale hospitalo-facultaire de l'hôpital de Louvain, IRB n°B403201213352) and was registed on ClinicalTrials.gov (NCT01367093).
The study will be conducted according to common guidelines for clinical trials (Declaration of Helsinki ICH-GCP, Version Seoul 2008, cf. ), including certification by an external audit according to ICH-GCP at the Institute for Medical Informatics, Biometrics and Epidemiology (IBE), Ludwig-Maximilians-University, Munich, Germany.
The study was carried out in accordance with the international standards for clinical trials, the declaration of Helsinki and the Good Clinical Practice Regulations.
The study was conducted in compliance with the protocol Good Clinical Practices and Declaration of Helsinki principles.
This survey was conducted in compliance with the protocol of Good Clinical Practices and Declaration of Helsinki principles.
The trial was conducted in compliance with the International Conference on Harmonization Good Clinical Practices, the Declaration of Helsinki and regulatory requirements of Mali.
The trial was conducted in compliance with principles set out by the International Conference on Harmonization Good Clinical Practices, the Declaration of Helsinki and the regulatory requirements of Burkina Faso.
The trial was conducted in compliance with the International Conference on Harmonisation Good Clinical Practices, the Declaration of Helsinki and regulatory requirements of Mali.
The study adhered to Good Clinical Practice, the Declaration of Helsinki and all applicable regulations.
