Fig. 1.

TOMMORROW study design framework. (Note: The numbers of participants in each arm of the diagram reflect calculated participants needed for the prespecified statistical power, not the number actually enrolled in the study. After a reassessment by the sponsor in 2015, the drug effect size assumption was increased from 30% to 40%. This change resulted in a decrease in the number of required study participants to achieve study goals from the initial target of approximately 5800 to 2800 and reduced the number of efficacy endpoint events from 410 to 202.). Abbreviation: BRAA, biomarker risk assignment algorithm.