Confidentiality {27}
All local legal requirements regarding data protection will be adhered to. All study findings and documents will be regarded as confidential. The Investigator and research team members must not disclose any information without prior written approval from the Sponsor.The pseudonymity of patients participating must be maintained. The patients will be recognized on CRFs and other documents by age and identification number throughout documentation and evaluation. Records that identify the patient personally (e.g., the signed informed consent) must be maintained in confidence by the investigator. The patients will be told that all study findings will be stored on a computer and handled in the strictest confidence.