The study complies with the Declaration of Helsinki, the local ethics committee of the University of Cologne has approved the research protocol.
The study complies with the Declaration of Helsinki, the local ethics committee of Beijing Anzhen Hospital of the Capital University of Medical Sciences has approved the research protocol.
Analysis of adverse events will be conducted according to good clinical practice, the ethical principles described in the Declaration of Helsinki, the local legal and regulatory requirements and those of the European Medicines Agency and the Federal Data Protection Law of Germany.
The study complies with the Declaration of Helsinki, the local ethics committee has approved the research protocol.
The study complied with the Declaration of Helsinki, the local ethics committee approved the study, and written informed consent was obtained from all participants.
Our study complies with the Declaration of Helsinki; the local Ethics Committee has approved the research protocol and informed consent has been obtained from the subjects.
The study was performed in compliance with the ICH E6 Note for Guidance on Good Clinical Practices (CPMP/ICH/135/95)5, the principles of the Declaration of Helsinki, local drug regulations, and standard operating procedures of the investigator, sponsor and CROs involved.
This prospective study was carried out according to the ethical principles of the Helsinki Declaration with approval of the local ethic committee (EK Nr: 1114/2009).
The study was conducted in accordance with the Declaration of Helsinki, local laws and the International Conference on Harmonization Good Clinical Practice Guideline, and approved by all relevant regulatory and independent ethics committees or institutional review boards.
After complete description of the study, all patients gave their informed consent, in accordance with the official standards of the 1964 declaration of Helsinki, local laws and regulations, was approved by the Ethical Committee of "S.
