2.4-Statistical analysis
Patient characteristics were presented as frequencies and percentages
for categorical data and means (SD) or medians (IQR) for continuous
data. The primary analysis of all outcomes followed the
intention-to-treat (ITT) principle. Between groups, we used the
Mann-Whitney-U test for comparing the time of success for HR, RR, and
CRS (SPSS Inc., version 25.0, Chicago, IL, USA). The longitudinal
analysis part of the study was performed non-parametrically with the
Brunner-Langer model for CRS conducted with a linear mixed model in a
parametric way for HR and RR. The Brunner-Langer model (F1-LD-F1) was
applied using web-based software (R software, version 3.5.2, package:
nparLD, R Foundation for Statistical Computing, Vienna, Austria;http://r-project.org). The PROC
MIXED procedure in the SAS software was used (Version 9.3; SAS
Institute, Cary, NC, USA) to perform linear mixed models in which
subjects were included as random effects. When there was a significant
interaction effect in the longitudinal analysis (P <
.1), the time effect was analyzed in each group, and groups were
compared at baseline and following time points (the baseline was
subtracted from these time points). The proportions of the treatment
failure, rescued patient, ICU admission, and AE were analyzed using
Fisher’s Exact test and, given with odds ratios (ORs) and 95%
Confidence Intervals (CIs). A 2-sided P < .05 defined
statistical significance.