Non‐inferiority margin (
TSS
The derived non‐inferiority margin for SIMPLIFY‐1 is presented in Table SIMPLIFY‐1 non‐inferiority margins.Abbreviations: MCT, meaningful change threshold; PGIC, Patient Global Impression of Change; TSS, total symptom score; ULCI, upper limit confidence interval.The non‐inferiority margin for the within‐patient group used the ULCI of the MCT, which was derived to be 8 points. The MCT of 8 points was determined using an anchor‐based method as previously described.