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Fig. 1 | Trials

Fig. 1

From: Update to the study protocol, including statistical analysis plan, for the multicentre, randomised controlled OuTSMART trial: a combined screening/treatment programme to prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies

Fig. 1

OuTSMART flow diagram. *Randomisation performed on results of a recruit’s first screening test. Those with human leucocyte antigen (HLA) antibodies (Ab) undergo no further screening as part of the trial (but serum will be stored for analysis of HLA Ab profiles later). †Those initially HLA Ab− undergo routine screening every 8 months. There is no second randomisation: if a recruit allocated to blinded standard care (group C) becomes HLA Ab+ (black lines), they remain in the standard care group (group A1 or A2). If in unblinded standard care group (D), they change to unblinded biomarker-led treatment care (group B1 or B2) (orange lines). €Numbers in each group are those anticipated at the end of study

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Trials

ISSN: 1745-6215