Catheterizations that were performed off-protocol were also recorded. Statistical Analysis We estimated that with 121 individuals in each treatment group, the analysis could have 80 percent or higher capacity to detect a mean between-group difference in the reduction from baseline of episodes of urgency bladder control problems of at least 0.8 episodes each day, assuming a standard deviation of 2.1, a two-sided type I error price of 0.05, and a 10 percent reduction to follow-up over the 6-month study period, and with one interim analysis performed.003), leaving a 0.047 significance level for the end-of-study major hypothesis test. For all efficacy analyses, we used a modified intention-to-treat approach, where data from all participants who underwent randomization and received a study medication and who had a baseline and at least one follow-up measure for the results under consideration were analyzed based on the group to which the participants had been assigned.Biopsy specimens of the vastus lateralis muscle mass were obtained from 4 individuals. Fibroblasts pelleted from cultures, leukocytes, and muscle-biopsy specimens were frozen in liquid nitrogen for make use of in research assays. Phosphoglucomutase 1 Activity and Expression Total RNA was extracted from fibroblast pellets, and PGM1 messenger RNA was quantified by means of a real-period polymerase chain response assay . Western blot evaluation was performed on cytosolic proteins extracted from fibroblast pellets with the use of a monoclonal anti-PGM1 antibody . Phosphoglucomutase 1 enzyme activity was assayed on extracts from fibroblasts spectrophotometrically, leukocytes, or skeletal-muscle tissue cells ., and the Supplementary Appendix). Green fluorescent proteins manufactured for retention in the endoplasmic reticulum was altered to contain an N-glycosylation site that, when glycosylated, causes loss of fluorescence .11 Glyc-ER-GFP was transfected into patient fibroblasts in tradition, and fluorescence was measured through quantitative microscopy .12,13 Glucose-1-phosphate was analyzed by means of a photometric method , and galactose-1-phosphate was assayed by using 14C-labeled UPD-glucose.14 Glycogen was extracted from fibroblasts and digested with amyloglucosidase as described previously.16 Glycogen content in fibroblasts from patients was also assessed by way of electron microscopy .