STATISTICAL PROCEDURES Clause Samples

STATISTICAL PROCEDURES. The primary objective of this study is to evaluate data obtained following six months of standard-of-care osteoporosis treatment, including treatment with alendronate, in subjects who have previously received 18 months of blinded treatment with BA058 Injection 80 µg/Placebo. Safety data will be obtained with clinical, laboratory and radiologic assessment. Following the initial six months of treatment in this study, subjects will then enter the long-term observational phase of this study during which the subjects will continue to receive alendronate treatment for an additional 18 months. The specific objectives of this study are to: · Provide additional information on safety in study subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide information on the vertebral fracture rate of subjects receiving six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide additional information on non-vertebral fractures and BMD change associated with six months of treatment with alendronate following 18 months of treatment with BA058 Injection 80 µg/Placebo. · Provide additional information on BMD change and osteoporosis status associated with 24 months of treatment with alendronate after 18 months of treatment with BA058 Injection 80 µg/Placebo. The analysis performed at six months will be used as a follow-up to the 18 month fracture endpoint for Study BA058-05-003. Additional analyses performed on data in this study will be descriptive in nature. Full details of the statistical procedures to be used will be provided in the Statistical Analysis Plan.
View SourceView Similar (4)
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 ...
View SourceView Similar (3)
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...
View SourceView Similar (3)

Related to STATISTICAL PROCEDURES

  • Statistical Data The statistical, industry-related and market-related data included in the Registration Statement, the Sale Preliminary Prospectus, and/or the Prospectus are based on or derived from sources that the Company reasonably and in good faith believes are reliable and accurate, and such data materially agree with the sources from which they are derived.

  • Medical Procedures 21.01 The Board shall distribute a copy of its Operating Procedures for administration of prescribed medication to pupils in schools and Procedures for health support services to each Teacher. 21.02 In accordance with Operating Procedure Special Education Services 8, a Teacher may refuse without prejudice a request to administer medications except in life-threatening situations.

  • Evaluation Procedures The following procedures for employee evaluation shall be utilized for the term of this Agreement: 1. Orientation materials related to evaluation procedures will be provided to all employees by the 10th school day. 2. Employees shall submit to their evaluator a complete listing of proposed objectives, and measurement activities related thereto, to be considered in the annual evaluation by the 25th school day. 3. The evaluator shall have completed by 30th school day annual objective setting conference with employee. 4. The evaluator shall by the 40th school day determine and shall provide the employee with a complete listing of actual objectives from those proposed by the evaluator and employee, and measurement activities from those proposed by the evaluator and employee, and measurement activities related thereto, that will be incorporated in the annual evaluation that the evaluator will prepare for the employee. The objectives and related measurement activities referred to herein shall be in accordance with the employee job description prescribed by the District. The District will make every attempt to have the number of objectives required to be uniform from site to site. 5. Within a reasonable time after the request, the evaluator shall be provided with a written progress report from the employee containing the latter's perception of the progress being made toward the achievement of the objectives prescribed in Item 3, above. During the course of the evaluation period, circumstances may change which may result in the modification of the original standards and objectives. These changes may be initiated by the supervisor or the employee. Agreement of both parties is required. 6. The evaluator, by the 145th school day, shall have conducted classroom observations in order to gather data on employee performance as the evaluator believes to be related to: A. The actual objectives and measurement activities described in Item 3, above; B. Other criteria for employee evaluation and appraisal that are established by the District ▇▇▇▇▇ Act Guidelines. At the discretion of the evaluator, tenured teachers may receive only one (1) formal instructional observation per year. Probationary teachers will receive two (2) formal instructional observations per year. Prior to conducting formal instructional observations regarding the teacher's duties related to the instructional objectives herein described, the teacher shall be notified of the observation prior to the beginning of the teacher's actual instructional day. Upon the request of the evaluatee or when, in the evaluator's judgment, additional instructional classroom observations are necessary, such observations may be conducted. Within a reasonable time, an employee shall be provided with a written statement regarding instructional observations that have been conducted. Such written statements shall contain a summary of the instructional activities observed, and any suggestions being made by the observer for possible improvement by the employee to include, but not be limited to, the following: 1) Specific directives for improvement 2) Assistance to implement such directives as (a) Provisions of additional resources; (b) Mandatory training programs designed to improve performance to be paid by the District. A final and written report of the achievement of objectives, and measurement information related thereto shall be submitted by the employee to the evaluator by the 140th school day. 7. The evaluator shall prepare a written District evaluation form of employee performance and transmit the evaluation to the employee. The employee may submit a written reaction or response to the evaluation and such response shall be attached to the evaluation and placed in the employee's permanent personnel file which shall be maintained in the District Office. Permanent employees shall be evaluated at least once every other year, and in no event later than 30 days before the last school day scheduled on the school calendar of the current school year. Probationary employees shall be evaluated at least once each year and in no event later than the 150th school day. 8. Employees who meet each of the following conditions shall be evaluated up to every five

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.‌ b. A description or identification of the statistical sampling software package used by the IRO.‌

  • Statistical Information Any third-party statistical and market-related data included in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate in all material respects.