Study Design
TRIAL-STIM was a multicenter, single-blind, parallel 2 group randomized trial (ISRCTN, ISRCTN60778781). The study was conducted across 3 participating sites in the United Kingdom: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital), Basildon and Thurrock University Hospitals NHS Foundation Trust, and Leeds Teaching Hospitals NHS Trust. The full study protocol has been published previously.