Randomization and Blinding
Comorbidity
Using a priori computer-generated permuted block design with random block sizes stratified by the 2 clinical sites, age (<60 or ≥60 years), and Charlson Comorbidity Index (CCI) score (<4 or ≥4), we randomized the participants in a 1:1 ratio to either the intervention or the control group. A central data manager conducted treatment assignments from a pregenerated random allocation sequence and informed the local research staff, who subsequently conducted a study visit with the participants to inform them of their treatment group. Although patients were not blinded given the nature of the study intervention, research staff assessing outcomes over telephone were blinded to treatment group.