Statistical analysis
Efficacy and safety analyses were performed in all randomized patients who received at least one dose of the study drug in groups defined by treatment assignment during the double-blind period, i.e., patients previously randomized to galcanezumab (GMB/GMB group) or to placebo (PBO/GMB group). The efficacy analysis included data from both the double-blind and OLE periods. Patients who have a baseline (from the double-blind phase) and at least one post-baseline observation were included in the analysis. Continuous efficacy endpoints were analyzed using a restricted maximum likelihood-based mixed model for repeated measures (MMRM). Binary efficacy endpoints with repeated measurements were analyzed with a categorical, pseudo-likelihood-based repeated measures analysis implemented using a generalized linear mixed model procedure (GLIMMIX). Except for the efficacy analyses on MHDs or categorical analysis of response rate (such as 50% response rate) derived from MHDs, in which the continuous value of baseline MHDs was used as a covariate, all other efficacy analyses included baseline number of MHDs category (< 8 vs ≥ 8) as a covariate in the MMRM and GLIMMIX model.Comparisons were claimed to be statistically significant if two-sided 