Provisions for post-trial care {30}
DISEASE, COMPLICATIONS
There are no provisions for post-trial care because we do not expect study related (serious) AEs beyond the risk of unrelated (S)AEs due to the natural course of the disease and (S)AEs related to standard of care. A previous first-in-man study including 13 patients demonstrated that the delivery of SBRT followed by surgical stabilization with or without decompression within 24 h is safe and feasible, and no wound complications were observed within 90 days following treatment [