Table 3

Summary of protocol amendments that impacted on trial design

ProtocolDateSummary of changes
2.011 March 2015Added details of the MRC systematic techniques for  assisting recruitment to trials (START) substudy
3.030 Sepember 2015Clarified 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.
4.003 March 2017Added 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 2018Due 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.