Randomisation
RECRUITMENT
Overall, 272 patients were screened between July 2007 and August 2010. Of the 272 screened patients, 14 were excluded for other medical reasons, and 58 participants decided that they did not want to participate in a research study. The remaining 200 patients were recruited and consented to the study giving a recruitment rate of 74% (Fig. CONSORT (Consolidated Standards of Reporting Trials) Flow Diagram demonstrating the flow of patients through the randomised clinical study