 The results of this research would then be analysed both at half way through data collection and at the end of data collection by the research team and the Sponsor and would be published as part of a research paper in a medical journal. This type of study design has been chosen to provide the research team with a high quality comparison between the two groups. Due to the nature of the treatment it was felt that it wasnt possible to implement any participant or clinician blinding to the methodology. 