Statistical Analysis
VTE, thromboembolism
THROMBOEMBOLISM
The aim of this study was to estimate the proportion of 28-day VTE in both treatment groups with a given precision. No formal hypothesis testing between the 2 treatment groups was intended. The sample size was assessed based on simulations (eMethods 3 in The safety population consisted of all patients who received at least 1 dose of study medication. The modified intention-to-treat (mITT) population consisted of all patients who were valid for the safety analysis and who had the full outcome assessment for the primary outcome measure of thromboembolism (for additional statistical methods, see eMethods 3 in 