 The clinical investigators will permit registry-related monitoring, audits, ethics committee review and regulatory inspections, thereby providing direct access to the facilities, personnel and to source datadocuments on request. The Sponsors staff or representatives will closely monitor the conduct of the registry so that any questions and problems that may arise can be promptly resolved. Such monitoring will also ensure that the registry is conducted in accordance with this registry protocol, including all amendments and with the requirements of national regulations and ISO 14155. 