Statistical analyses
SE, PMD
REGRESSION, SECONDARY, INTRAOCULAR PRESSURE
All primary analyses (primary and secondary outcomes including safety outcomes) were evaluated by intention-to-treat (ITT) analysis. Analysis was completed on received data, with every effort made to follow-up participants to minimize potential for bias. Final analyses were conducted after the final visit of the final patient of the main trial once the data had been cleaned and locked, then unblinded. No imputation of missing data was conducted. The analysis of visual data included data from the most affected eye at baseline as defined by PMD, analysis of intraocular pressure was performed on the mean average of both eyes. Statistical analysis was performed in R v4.0.0 (R Foundation for Statistical Computing, Vienna, Austria). Data were reported as means and SD [with median and interquartile range (IQR) for non-normal data], and standard error (SE) and 95% CI where appropriate. Hierarchical linear regression models were used to analyse repeated measures of the primary and secondary outcomes and to estimate differences adjusted for baseline values. In these models, population-level effects (also known as fixed effects) comprised the intercept, time as a factor variable and the two-way interaction of treatment arm and time as a factor variable to model changing treatment effects over time. Group-level effects (also known as random effects) comprised patient-level adjustments to the intercept. The threshold for statistical significance was pre-specified at 0.1.