The design was a parallel-group, randomized, controlled trial with 2 arms.
A randomized trial with 2 arms (mitral valve surgery randomized to CSD and cardiomyopathy randomized to medical therapy alone or with CSD) enrolled 300 patients.
Secondary endpoints included comparison of the changes in SGRQ score, spirometric lung function, BODE index, and exacerbation frequency at 26 weeks between the 2 arms.
We included any study design in which there were 2 arms and an n > 100, if at least 1 of the arms was a nonantimuscarinic therapy or any comparative trial, regardless of number, if at least 2 arms were nonantimuscarinic therapies for overactive bladder.
Up to 50 sites in Japan and the United States will enroll 286 subjects (271 evaluable) in each of 2 arms, for a total sample size of 572 subjects (542 evaluable).
RESULTS: At this preliminary analysis, no statistically significant difference in the overall response rate, duration of response, time to disease progression, or median survival was observed between the 2 arms.
Figure 4 illustrates the timing of the first exacerbation during the study in the 2 arms, and the probability of not having an exacerbation favors the lung flute (p = 0.03).
Safety data was compared between the 2 arms of the study, while immune and PSA data were assessed by comparisons made between pre- and post-vaccine phases in all 24 patients.
Although the data were pooled from the 2 arms of a negative randomized trial, we included study arm as a variable in the analyses in order to control for a possible effect of the intervention.
By means of these landmarks and anthropometric data, a 9-segment model (2 legs, 2 thighs, 1 pelvis-trunk, 2 arms and 2 upper arms) was developed to estimate the total body CoM.
Patient characteristics were well-balanced between the 2 arms.
