<qa>  What is the standard of care?Radiographic images will be collected as per standard imaging procedures standard of care at the investigation site following patient examinations at discharge, 6 and 12 weeks, 6 and 12 months. Digital de-identified images will be sent to GCTM. Transfer of imaging data to GCTM and handling of the de-identified imaging data at GCTM will be performed according to GCTM standard procedures. More details are described in the imaging manual. 