2.0 | 11 March 2015 | Added details of the MRC systematic techniques for assisting recruitment to trials (START) substudy |
3.0 | 30 Sepember 2015 | Clarified inclusion and exclusion criteria; added more details about training participants to use trial treatments; procedures clarified for digital images outcome analyses; changes to adverse events (AE) handling for erythema (grade 1 and 2 are not AE, but expected reactions) and amendment of prespecified subgroup analysis to remove a comparison of active and inactive patches (as by definition all target patches will be active), and add a subgroup analysis evaluating response of target patch by region of the body. |
4.0 | 03 March 2017 | Added details of the nested process evaluation; updates to the safety handling section; introduction of an online automated the blind brake procedure; change to sample size following sample size review by the Data Monitoring Committee (DMC). |
5.0 | 18 January 2018 | Due to trial timelines some participants will not receive the full 12 month follow-up but will receive quality of life questionnaires and study feedback questions; Updates to statistical analyses section to reflect the statistical analysis plan; addition of output testing of NV-UVB devices after end of treatment phase. |