Analysis of Secondary Endpoints Sample Clauses

Analysis of Secondary Endpoints. Secondary efficacy endpoints are: · The difference in absolute weight loss between randomization and end of treatment (week 56) for *** and *** groups. · The difference in percent of subjects who achieve a reduction in total body weight of at least 10% between randomization (baseline) and end of treatment (week 56) for *** and *** groups. · The difference in change in waist circumference (randomization to week 56) for *** and *** groups. The ITT population will be employed to evaluate all secondary efficacy endpoints, and a step down strategy analogous to that used for the primary endpoint will be implemented to protect the overall alpha levels for these analyses. The difference in absolute weight reduction and the difference in change in waist circumference at week 56 from baseline will also be compared using the same *** as the primary end point. ***, with ***and *** and ***, will be used to compare the probability of reaching 10% body weight reduction from randomization (baseline) to week 56 between treatment groups.
AutoNDA by SimpleDocs
Analysis of Secondary Endpoints. Comprehensive details of secondary endpoints will be outlined in the SAP. The following considerations will guide development of these secondary endpoints: 1. For Part A, the mean response for each cohort incorporating data from all visits will be compared using repeated measures ANOVA test. For part B, Generalized Estimating Equations (GEE) models will allow estimation of the change over time in the response variable. Potential confounders that affect the outcome will be identified and included in all multivariate models. 2. For Part A, Cohort 3 subjects will be stratified by mild versus severe lung disease, defined as upper and lower FEV1 percentiles and endpoints will be compared across the phenotype extremes as well as correlated with FEV1 percent predicted as a continuum. 3. Data will be screened for potential outliers and influential values. In addition, some response variables may require log transformation to account for non-constant variance or skewness. Either the Xxxx Xxxxxxx U test or the Wilcoxan Signed Rank test may be applied for secondary endpoints for which parametric distributional assumptions do not hold. 4. For select sub-studies, rather than examining mean response or Area Under the Curve (AUC), the primary endpoints will be re-examined using a different definition, either as change in slope or as percent of responders reaching a pre-defined endpoint. 5. For Part B, subgroup analysis of the primary endpoint by classifying subjects into extreme phenotypes (e.g., FEV1 percentiles) will help identify markers responsive to lumacaftor/ivacaftor.
Analysis of Secondary Endpoints. Secondary efficacy endpoints that are based on continuous data, including changes from baseline to week 28 in waist circumference and ***, will be evaluated in a manner similar to the primary endpoint. Categorical variables, including the proportion of subjects achieving 10% reductions in body weight at week 28 will be evaluated by ***. Analyses of secondary endpoints will also be based on the ITT population, and a step down strategy analogous to that used for the primary endpoint will be implemented to protect the overall alpha levels for these comparisons.
Analysis of Secondary Endpoints. ‌ Summary statistics (mean, standard deviation, median and range) of lung function parameters, sputum density, CFRSD-CRISS, and blood inflammatory markers for each visit and changes from baseline will be presented by treatment group. Descriptive statistics will be used to summarize the proportion of subjects initiating acute antibiotics (by route) and differences in proportions between the study arms will be estimated with accompanying 95% CIs. Changes in lung function parameters (FVC in liters, FVC % predicted and FEV1 % predicted), sputum bacterial density, CFRSD-CRISS, and inflammatory markers will be analyzed using MMRM. Adjusted means and 95% CIs will be presented for each visit. Treatment comparisons of the average response at each visit will be generated within the MMRM model based on the linear contrast of the average using the estimated LSMeans at Days 14, 28, and 56. A log transformation will be used in all analyses of quantitative sputum culture counts and blood inflammatory markers. Change in bacterial density will include only those subjects with the pathogen at baseline. Additional descriptive analyses will be performed to summarize the disappearance and emergence of the pathogens and their susceptibility to gallium. For those subjects randomized to receive IV gallium, we will determine of the Css and t1/2β by analyzing Days 1, 6, 14, 28 and 56. Clearance will be determined as the ratio of the infusion rate to the steady state concentration immediately prior to completion of the infusion. The t1/2β will be determined as 0.693/K where K is the elimination rate constant determined by the slope of the concentration/time curve after the infusion has been discontinued. To avoid unblinding, samples will only be assayed at the end of the completion of the trial.
Analysis of Secondary Endpoints 

Related to Analysis of Secondary Endpoints

  • Money Market Fund Compliance Testing and Reporting Services Subject to the authorization and direction of the Trust and, in each case where appropriate, the review and comment by the Trust’s independent accountants and legal counsel, and in accordance with procedures that may be established from time to time between the Trust and the Administrator, the Administrator will:

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall: (a) supervise all aspects of the operations of the Funds; (b) obtain and evaluate pertinent information about significant developments and economic, statistical and financial data, domestic, foreign or otherwise, whether affecting the economy generally or the Funds, and whether concerning the individual issuers whose securities are included in the assets of the Funds or the activities in which such issuers engage, or with respect to securities which the Advisor considers desirable for inclusion in the Funds' assets; (c) determine which issuers and securities shall be represented in the Funds' investment portfolios and regularly report thereon to the Board of Trustees; (d) formulate and implement continuing programs for the purchases and sales of the securities of such issuers and regularly report thereon to the Board of Trustees; and (e) take, on behalf of the Trust and the Funds, all actions which appear to the Trust and the Funds necessary to carry into effect such purchase and sale programs and supervisory functions as aforesaid, including but not limited to the placing of orders for the purchase and sale of securities for the Funds.

  • Evaluation Criteria 5.2.1. The responses will be evaluated based on the following: (edit evaluation criteria below as appropriate for your project)

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Random Testing Notwithstanding any provisions of the Collective Agreement or any special agreements appended thereto, section 4.6 of the Canadian Model will not be applied by agreement. If applied to a worker dispatched by the Union, it will be applied or deemed to be applied unilaterally by the Employer. The Union retains the right to grieve the legality of any imposition of random testing in accordance with the Grievance Procedure set out in this Collective Agreement.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Sampling and Analysis The Seller has sole responsibility for quality control of the coal and shall forward its “as loaded” quality to the Buyer as soon as possible. The sampling and analysis of the coal delivered hereunder shall be performed by Buyer and the results thereof shall be accepted and used for the quality and characteristics of the coal delivered under this Agreement. All analyses shall be made in Buyer’s laboratory at Buyer’s expense in accordance with ASTM standards where applicable, or using standards mutually acceptable to both parties. Samples for analyses shall be taken by any ASTM standards or standards mutually acceptable to both parties, and may be composited and shall be taken with a frequency and regularity sufficient to provide reasonably accurate representative samples of the deliveries made hereunder. Seller represents that it is familiar with Buyer’s sampling and analysis practices, and finds them to be acceptable. Buyer shall notify Seller in writing of any significant changes in Buyer’s sampling and analysis practices. Any such changes in Buyer’s sampling and analysis practices shall, except for ASTM or mutually agreeable changes in practices, provide for no less accuracy than the sampling and analysis practices existing at the time of the execution of this Agreement, unless the Parties otherwise mutually agree. (1) part shall be used for analysis by Buyer; one (l) part shall be used by Buyer as a check sample, if Buyer in its sole judgment determines it is necessary; one (1) part shall be retained by Buyer (LG&E) until the twenty-fifth (25th) of the month following the month of unloading (the “LG&E Disposal Date”) or Buyer (KU) until thirty (30) days after the sample is taken (the “KU Disposal Date”), the LG&E Disposal Date and the KU Disposal Date are collectively the “Disposal Date”), and shall be delivered to Seller for analysis if Seller so requests before the Disposal Date; and one part (“Referee Sample”) shall be retained by Buyer until the Disposal Date. Seller shall be given copies of all analyses made by Buyer by the tenth (10th) business day of the month following the month of unloading. Seller, on reasonable notice to Buyer shall have the right to have a representative present to observe the sampling and analyses performed by Buyer. Unless Seller requests a Referee Sample analysis before the Disposal Date, Buyer’s analysis shall be used to determine the quality of the coal delivered hereunder. The Monthly Weighted Averages shall be determined by utilizing the individual shipment analyses. If any dispute arises before the Disposal Date, the Referee Sample retained by Buyer shall be submitted for analysis to an independent commercial testing laboratory (“Independent Lab”) mutually chosen by Buyer and Seller. For each coal quality specification in question, a dispute shall be deemed not to exist and Buyer’s analysis shall prevail and the analysis of the Independent Lab shall be disregarded if the analysis of the Independent Lab differs from the analysis of Buyer by an amount equal to or less than: (i) 0.50% moisture (ii) 0.50% ash on a dry basis (iii) 100 Btu/lb. on a dry basis (iv) 0.10% sulfur on a dry basis. For each coal quality specification in question, if the analysis of the Independent Lab differs from the analysis of Buyer by an amount more than the amounts listed above, then the analysis of the Independent Lab shall prevail and Buyer’s analysis shall be disregarded. The cost of the analysis made by the Independent Lab shall be borne by Seller to the extent that Buyer’s analysis prevails and by Buyer to the extent that the analysis of the Independent Lab prevails.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!