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Table 3 Summary of protocol amendments that impacted on trial design

From: A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

Protocol Date Summary of changes prior to start of recruitment
 V 2.0 1 August 2013 • Eligibility criteria amended to include children with at least one patch of eczema on the trunk or limbs
Protocol Date Summary of changes after start of recruitment
 V 3.0 11 February 2014 • The number for filaggrin genotype mutations which the lab will be looking for has been increased from 4 to 6, to now also include: ‘up to 6 mutations’ (depending on quantity/quality of DNA) and the additional two are 3702delG and 3673delC
• Introduction of details of optional qualitative component for study participants (parents and children) to take part in at the end of the 8-month RCT
  1. RCT randomised controlled trial