Ethics approval and consent to participate {24}
The trials will be initiated at the respective study sites only after all required legal documentation has been reviewed and obtained, and the study protocol has been reviewed and approved by the responsible IRB/IEC at both central and local levels. The same applies for the implementation of changes introduced by amendments. Receipt of signed and dated informed consent represents inclusion criteria for the trial. A trial investigator or delegate will obtain informed, freely given, written consent from each subject via a consent form, after confirming that the subject understands the study design and the content of the form.