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Tiwari BK, Pandey KB, Abidi A, Rizvi SI

The 2 individual patient-reported components (stool frequency and rectal bleeding) are part of the Mayo score and were not powered for statistical significance Correlation of depicted PROs to Week 6 and Week 52 primary end points was not evaluated in the analysis GEMINI I TRIAL EXPLORATORY END POINTS: PATIENT-REPORTED OUTCOMES Overall population compared with placebo Not powered for statistical significance

doi: 10.1016/j.bbamem.2008.07.030

Patients need to be committed to the process and have realistic expectations

On Day 1 and Day 6, standardised lunch and dinner were served at approximately 5 h and 12 h after NAC administration, respectively