3.1
NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 6 sources, which was discussed by the committee. The evidence included 2 non-randomised clinical trials, 1 randomised clinical trial (including a dose evaluation study and an open-label confirmation study), 1 randomised controlled clinical trial and 2 additional papers that reported longer-term outcomes from the 2 randomised clinical trials. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.