 1. Patients screened and enrolled in the Physica KR follow-up clinical study according to all inclusion criteria. K-06- Study protocol 30102013 v 1.0 approved by the Health Research Authority NRES Committee East of England - Cambridge East on February 13th 2014 and by the RD Department of The Royal Bournemouth and Christchurch Hospital NHS Foundation Trust on March 7th 2014; 