Analyses were per protocol (included data only when study subjects remained on study protocol therapy as there was substantial attrition after 48 h). Descriptive statistics were computed for each treatment group. For all comparative analyses between the two treatment groups, chi-square test (or Fisher’s exact test) for categorical variables and Wilcoxon–Mann–Whitney test for continuous variables were performed, respectively. All statistical comparisons were con- ducted using SAS (version 9.4).