Fig. 2From: A small population, randomised, placebo-controlled trial to determine the efficacy of anakinra in the treatment of pustular psoriasis: study protocol for the APRICOT trialDiagram depicting study design and flow of participants. Decision 1: If placebo does as well or better than treatment arm for both of the two outcomes, Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI) or fresh pustule count, the study will STOP. If the treatment arm does better than the placebo arm for at least one outcome the study will proceed (GO). These decisions will be made on the basis of the mean outcome values for each arm. Decision 2: Choice of the primary outcome. If the trial continues (‘GO’), the choice of the primary outcome will by default be the fresh pustule count. If the PPPASI is determined to be more reliable and discriminating than the fresh pustule count then the primary outcome will be PPPASI. ITT Intention to treatBack to article page