QT interval
The upper limit of the 2-sided 90% confidence interval (CI) for least squares (LS) mean differences in QTc using Fridericia’s formula (QTcF) was < 10 ms for all time points during Cycle 1, including those on D4 and D7 assessed in the primary analysis (Fig. QTcF change from baseline during C1. Baseline is defined as the last average of the planned triplicate 12-lead electrocardiogram measurements available prior to the first dose of GO. LS means estimated from a linear model with visit/time post-dose as fixed effect and unstructured variance/covariance matrix for the repeated measurements with CI using approximate t-distribution with degree of freedom by the Kenward–Roger method. The time points assessed in the primary analysis of QTcF were D4 (at 0 h) and D7 (at 0, 2, 4, and 6 h). 