10.2 Ethical conduct of the study The procedures set out in this protocol, pertaining to the conduct, evaluation, and documentation of this study, are designed to ensure that the investigators abide by GCP Guidelines and under the guiding principles detailed in the declaration of Helsinki. The study will also be carried out in keeping with applicable local law(s) and regulation(s). This may include an inspection by regulatory authority representatives at any time, including allowing direct access of source documents to the regulatory authority.