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All four studies were conducted in compliance with the ethical principles that originated in the Declaration of Helsinki regarding biomedical research on human subjects and informed consent regulations.
The study was conducted at two sites in Germany in accordance with the ethical principles that originated in the Declaration of Helsinki.
The study was conducted in accord with the ethical principles that originated in the Declaration of Helsinki, and the study protocol was approved by the institutional review board or independent ethics committee at each study site.
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The study was conducted in accordance with the ethical principles originating in the Declaration of Helsinki.
The study was conducted in accordance with the ethical principles originating in the Declaration of Helsinki and the International Conference on Harmonization (ICH) guideline E6: Good Clinical Practice.
The study was conducted in accordance with the ethical principles originating in the Declaration of Helsinki and with local Institutional Review Board approval at each participating center.
The study was conducted in accordance with the ethical principles originating in the Declaration of Helsinki, and in compliance with International Conference on Harmonisation, Good Clinical Practices, and regulatory guidelines.
The study was performed in accordance with ethical principles originating in the Declaration of Helsinki and consistent with ICH/Good Clinical Practice, applicable regulatory requirements and AstraZeneca's policy on bioethics.
The study (ClinicalTrials.gov identifier: NCT01043185) was designed and performed in accordance with ethical principles originating in the Declaration of Helsinki, and the study was consistent with guidelines of the International Conference on Harmonisation and Good Clinical Practice, regulatory requirements, and the AstraZeneca policy on bioethics and human biological samples.
The study protocol (ISN/protocol 9463-EC-0001) was approved by the independent Ethics committee or institutional review board at each center and was conducted in accordance with the ethical principles that originate in the Declaration of Helsinki.
This study was approved by a central institutional review board, Concordia Clinical Research (Cedar Knolls, NJ, USA), in accordance with the ethical principles originating from the Declaration of Helsinki and in compliance with the International Conference on Harmonization guidance on Good Clinical Practice.
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