Statistical Analysis
obesity, garadacimab, diabetes
REGRESSION, OBESITY, HYPERTENSION, DIABETES
Comparisons of the two study groups for the primary efficacy analysis—and all-cause mortality, incidence of TI and proportion of patients using BiPAP/CPAP—were assessed by Firth logistic regression model including treatment group, age group as a continuous covariate, gender (male or female) and baseline comorbidities (yes or no) as categorical covariates. Comorbidities included hypertension, diabetes and obesity [defined as body mass index (BMI) ≥ 30 kg/mNIAID ordinal scale frequency and proportion of patients with an improvement from baseline of ≥ 2 points were summarised using descriptive statistics. Hospital length of stay was analysed using a Cox model, including treatment group, gender, age as a continuous covariate and baseline comorbidities as categorical covariates. Hazard ratios, 95% CIs and 2-sided Wald Efficacy outcomes were assessed in the intention-to-treat (ITT) population, comprising all screened patients with randomisation numbers who were assigned to treatment. The ITT population was analysed according to the treatment to which patients were randomised, regardless of the treatment they received. Safety was assessed according to the treatment each patient received, regardless of randomisation. Using a 2-sided α = 0.05 and 1:1 randomisation ratio for garadacimab versus placebo, a total of 124 patients were required to be randomised (garadacimab 