Statistical analysis
EVENT
All efficacy analyses were conducted for the intent-to-treat (ITT) population, which consisted of all randomized eyes that received at least 1 dose of study treatment. Comparisons were made between ACP 2 mg and ACP 4 mg with their corresponding sham, as determined in a prespecified statistical analysis plan. The analyses were repeated at month 18 using the same conventions as were prespecified for month 12. It should be emphasized that month 18 analyses were descriptive and not protected from a type I error; hence, no P-values are reported to avoid any misinterpretation of the results. The primary efficacy analysis and 18-month analysis used the mixed-model with repeated measures (MMRM) analysis to compare the treatment arms, which uses all observed data with the assumption of data missing at random. All safety analyses were performed on the safety population, which included all subjects who received at least 1 dose of the study drug. In the event participants received a dose different from the one assigned according to the randomization schedule, safety analyses were conducted according to the dose received rather than according to the dose assigned by randomization. Safety measures were calculated based on observed cases.