- Evidence of a personally signed and dated informed consent document by the patient
indicating that he/she (or a legally acceptable representative) has been informed of
all pertinent aspects of the study is a requirement for inclusion.
- Additional inclusion criteria reflect the approved label for Thelin as outlined in the
- There are no specific exclusion criteria for enrollment in the Thelin Patient Safety
Registry, with the exception of those reflected in the approved label for Thelin as
outlined in the SmPC.