The plotted values represent observed data (±SEM). The dotted lines represent the average treatment effect across all post-baseline visits. The p-values were obtained from a mixed-model repeated measures (MMRM) analysis. Covariates were baseline % predicted FEV1, treatment, visit, treatment-by-visit interaction, baseline % predicted FEV1-by-visit interaction, and the stratification factors of baseline inhaled antibiotics (yes vs no), baseline age (<18 vs ≥18 years), and baseline % predicted FEV1 (40 to <65% vs ≥65 to 90%).
Abbreviations: FEV1 = forced expiratory volume in 1 second, ITT = intent-to-treat, MMRM = mixed-model repeated-measures