Statistical analysis
The target sample size was 30 patients (invimestrocel group: N = 20; standard group: N = 10) based on feasibility and not statistical power.The modified intent-to-treat (mITT) analysis set included all randomized patients with at least one efficacy endpoint. The safety analysis set (SAS) included all randomized patients. Efficacy and safety analyses were performed on the mITT set and SAS, respectively. For continuous data, summary statistics were calculated; for categorical data, frequencies are presented. For the primary endpoint, means with 95% confidence intervals (CIs) are presented for each treatment group and an analysis of covariance was performed with treatment group, age at enrollment (< 75 years, ≥ 75 years), PaO