The study will be conducted according to the protocol and in strict compliance with ICH GCP, the Declaration of Helsinki and all applicable regulatory requirements. Before the start of the study, the study protocol, the investigator brochure and other applicable documents will be submitted to independent Ethics Committees (EC) and responsible national and local authorities, as required by each participating country's regulations. The study can start only after the favourable opinion of the EC of the Coordinating Centre. The Coordinating Centre will inform the investigators in writing that all ethical and legal requirements have been met before the first patient is enrolled in the study. After the protocol has been accepted, substantial amendments to this protocol require the approval by the Coordinating Centre. After the end of the study, a final study report will be prepared and distributed to regulatory authorities and ECs as required by applicable regulations. Before a patient can participate in the study, patient's informed consent needs to be obtained according to GCP and the legal requirements of the country concerned. Patient information sheet and consent form must have been reviewed and approved by the responsible EC. The investigator or an authorized designate will explain the nature, purpose, scope and course of the study, including information on the investigational therapy, potential benefits and risks to the patient. In addition to oral information, the patient will receive a written patient information sheet containing all relevant information. Sufficient time will be allowed to discuss any questions raised. Only after this process is completed, consent for participation may be given. Consent must be obtained prior to any study specific procedure and with sufficient time before a study related intervention as per local requirements. The consent form must be personally signed and dated by the individual giving consent and by the investigator or designee who lead the informed consent process with the patient. The consent form must be retained by the investigator as part of the study records. In addition, the patient will receive a copy of the patient information sheet and a copy of his/her signed and dated consent form. Confirmation that consent was obtained will also be documented in the medical records and on the eCRF. Should a protocol amendment be made, the patient information sheet may need to be revised to reflect the change(s) of the protocol. After the EC has approved the revised information sheet and consent form, it is the responsibility of the investigator to inform all active patients affected by the change, and to receive their written consent for continuation in the study.