Statistical Analysis Plan and addendums for MissionEB trial
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posted on 2025-07-14, 18:08 authored by Matthew BursnallMatthew Bursnall, Munyaradzi DimairoMunyaradzi Dimairo<p dir="ltr">Statistical Analysis Plan (SAP) for the MissionEB trial, a double blinded placebo control study of Mesenchymal Intravenous Stromal cell Infusions in children with recessive dystrophic Epidermolysis Bullosa. The trial uses a 2by2 cross-over design with an internal dose de-escalation phase.</p><p dir="ltr">This is a pre-planned finalised statistical analysis plan (SAP) detailing statistical methods used for the analyses of the MissionEB Trial. Amendments from previous versions with explanations are detailed in the SAP and in the addenda. Details concerning trial registration, funding, and research ethics are provided on the leading page of the SAP.</p><p dir="ltr"><br></p>
Funding
NIHR127963
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