Statistical Analysis
REGRESSION, SECONDARY
The sample size calculation has been described elsewhere.The primary analysis compared primary and secondary outcomes between randomized groups including patients who completed the 36-month follow-up assessment.Linear regression methods with adjustment for baseline outcome scores and stratification/minimization variables were used to compare continuous outcomes. Logistic regression analysis adjusting for stratification/minimization variables were used to compare binary outcomes.All analyses were performed using STATA v14.0 (StataCorp LP).