REGULATORY AND ETHICAL CONSIDERATIONS GOOD CLINICAL PRACTICE This study will be conducted in accordance with: •Good Clinical Practice (GCP), •as defined by the International Council on Harmonisation (ICH) •in accordance with the ethical principles underlying European Union Directive 2001/20/EC •United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) •applicable local requirements. The study will be conducted in compliance with the protocol. The protocol and any amendments and the participant informed consent will r eceive approval/favorable opinion by Institutional Review Board/Independent Ethics Committee (IRB/IEC) , and regulatory authorities according to applicable local regulations prior to initiation of the study. All potential serious breaches must be re ported to the Sponsor or designee immediately. A potential serious breach is defined as a Quality I ssue (eg, protocol deviations, etc) that is likely to affect to a significant degree one or more of the following: (1) the physical, safety, or mental integrity of one or more subjects/participants; (2) the scientific value of the trial (eg, reliability and robustness of generated data). Items (1) or (2) can be associated with either GCP Regulation(s) or Trial protocol(s).