STATISTICAL PROCEDURES Clause Samples

STATISTICAL PROCEDURES. The purpose of this section is to outline prospectively the types of analyses and presentations of data that will answer the study objectives outlined in the protocol, and to explain how the data will be handled and analyzed, adhering to commonly accepted standards and practices of biostatistical analysis in the pharmaceutical industry. The primary objective of this study is to determine the safety and efficacy of BA058 80 µg when compared to a matching placebo (Placebo) for prevention of vertebral fracture in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis. The secondary objectives of this study are to determine the safety and efficacy of BA058 80 µg when compared to Placebo for prevention of non-vertebral fractures and change in vertical height. Additional secondary efficacy outcomes include BMD (spine, hip and femoral neck) and safety (hypercalcemia) when compared to teriparatide in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis. The specific objectives of this study are to: · Determine the comparative efficacy of 18 months of treatment with BA058 80 µg on reduction of vertebral fracture incidence in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis when compared with Placebo. · Determine the comparative efficacy of 18 months of treatment with BA058 80 µg on lumbar spine, hip, and femoral neck bone mineral density (BMD) in otherwise healthy ambulatory postmenopausal women with severe osteoporosis when compared to teriparatide. · Determine the comparative efficacy of 18 months of treatment with BA058 80 µg on reduction of non-vertebral fracture incidence in otherwise healthy ambulatory postmenopausal women at risk of fracture from severe osteoporosis when compared with Placebo. · Determine the overall safety and tolerability of 18 months of treatment with BA058 80 µg, and specifically the number of patients with hypercalcemic events, in otherwise healthy postmenopausal women with severe osteoporosis when compared to teriparatide and Placebo. · Provide additional evidence of bone safety through histomorphometric assessment of bone biopsy samples in a subset of patients from the BA058 80 µg and Placebo groups. · Provide additional evidence of renal safety through radiological assessment by CT scan of a subset of patients from the BA058 80 µg, Placebo and teriparatide groups. A sample size of 622 patients per treatment ...

STATISTICAL PROCEDURES. The scores of alternate versions were computed. The demographic statistics of the sample including age, sex, total score of all included versions of NDI were described by mean, standard deviation (SD), median, interquartile range, minimum and maximum value. We performed the Wilcoxon signed rank test to perform a non-parametric comparison between NDI scores since the total score of NDI-10 was computed from ordinal scale. Agreement of ▇▇▇▇▇ solutions The normal distribution of mean differences of all three comparisons were inspected by the histogram. Using the B&A plots, we summarized the individual agreement between each of the identified NDI versions by the mean difference and the 95% limits of agreement (LoA; ±1.96 times the standard deviation). To test the average agreement and differences between each NDI score, we examined the mean differences by one-sample t-test(▇▇▇▇▇▇▇▇▇, 2015). We reported the sample size for each comparison, the degree of freedom, mean differences with p-value and 95% confidence interval (CI), standard error of differences (SE). Transformations including logarithmic and linear transformations were applied to normalize the non- uniform pattern of the bias on the plot. For instance, when the B&A plot shows a linear relationship between differences and means, (the differences measurement bias start with negative value and then becomes positive while the magnitude of the mean increases), we can regress differences between the methods (D) on the average of the two methods (A) by D = b1 × A + b0. The 95% LoA for the regression should build on the SD of the residual (SDres) from the established model (±1.96 times SDres) (▇▇▇▇▇ & ▇▇▇▇▇▇, 1999). All analysis was performed by IBM SPSS statistics, Version 25.0 (IBM Corporation, Armonk, NY). We considered a significance level of p ≤ 0.05 as statistically significant. Results Study Selection and NDI version identification Initially, our search yielded 303 publications. After removing the duplications, 296 articles were left. Six studies were then selected for full text review after title and abstract review. Of these, two ▇▇▇▇▇ solutions that met the study criteria were identified from 2 individual studies including a 8-item version NDI (NDI-8) developed by ▇▇▇ ▇▇▇ ▇▇▇▇▇ and colleagues(▇▇▇ ▇▇▇ ▇▇▇▇▇ et al., 2009) which was based on ▇▇▇▇▇ criteria, and a 5-item version NDI (NDI-5) developed by ▇▇▇▇▇▇ and ▇▇▇▇▇▇▇▇▇ (2013) based on conceptual and ▇▇▇▇▇ criteria (▇▇▇▇▇▇ & ▇▇▇▇▇▇▇▇▇, 2013). This al...