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Analysis set includes all randomized patients who received at least 1 dose of study drug and had sufficient blood sampling to allow for evaluation Blood samples for PK analyses were obtained within 30 minutes before dosing at study visits on Weeks 0, 6, 8, 14, 22, 30, 38, 46, and 50, and at any time during study visits at Weeks 7, 51, and 52 Vedolizumab SC dosing at 108 mg every 2 weeks was calculated to provide generally comparable drug exposure to that achieved with vedolizumab IV 300 mg every 8 weeks based on average serum vedolizumab concentrations at steady state

However, in a significant subset of patients, these symptoms represent a coherent, quantifiable failure of cellular energy production caused by environmental mycotoxins