Furthermore, we did not collect data for demographic differences between the study groups except for gender.
The clinical outcomes did not differ significantly between the study groups, except for the laparoscopic operation time.
Patients' baseline demographic, clinical, and surgical characteristics were similar between the study groups, except for pre-operative beta-blocker use (dexamethasone group 69% versus placebo group 60%, P = 0.046) (Table 2).
Last, RR-interval power spectral analysis did not find any significant difference between the study groups, except for a lower LH/HF value in the group with Holter ECG-documented sustained VT with respect to the one without.
Except for headache, which was more common in participants in the VivaGel® arm, non-GU AEs did not appear different between study groups.
Table 1 shows that at inclusion in the study, patients' characteristics were well balanced between the three study groups, except for sex.
Baseline measures of the biochemical, clinical, and psychosocial outcomes were balanced between the two study groups, except for high density lipoprotein cholesterol (table 2).
The quality of recovery and all the VAS assessments were comparable between the two study groups, except for the VAS at the 24th hour postoperatively which was significantly lower in the levobupivacaine group.
23 Other safety outcomes were consistent between the two study groups, except that the add-on strategy resulted in a numerically higher proportion of patients who had transaminase level increases compared with the switch strategy.
There were no significant demographic differences between the study groups or between the two sites except that one center (Cincinnati) usually delivered these fetuses by cesarean whereas the other (Louisville) usually delivered such fetuses vaginally.
