• Inclusion for a one year period of patients

• Study start per site once the first patient is included

• Electronic database will be made available. Once a month an update of the database is provided to the central data collection centre. At the centre a contact person will coordinate the data handling

• The members of the study group will receive on a regular base an update of the data collected

• The data analysis is supported by a Steering committee that are members of the study group

• The Steering committee is composed of 6-8 international members, a chairman and a representative from the sponsor.