Secondary outcomes include measures of efficacy of NRL001 compared with placebo following 8 weeks treatment ; safety and tolerability ; evaluation of plasma pharmacokinetics ; establishment of any pharmacokinetic/pharmacodynamic relationship to adverse events ; dose-response relationship ; the efficacy of NRL001 therapy at 4 and 8 weeks assessed by the Vaizey score ; and QoL using the Faecal Incontinence Quality of Life and the EQ-5D-5L Healthcare Questionnaires following 4 and 8 weeks NRL001 therapy .