Analysis of Primary Endpoint Sample Clauses

Analysis of Primary Endpoint. Based on evidence from prior studies, it is hypothesized that six months of oral GSH will be associated with an improved weight-for-age z-score as compared to six months of oral placebo. Therefore the null hypothesis is that there is no difference between treatment groups in the 6 month change in weight-for-age z-score. The primary endpoint is the difference between the GSH and placebo groups in the change in weight-for-age z-score from Visit 2 to Visit 4 (Week 24). The difference between treatment groups will be estimated using a linear mixed effects model which will incorporate Visit 3 (Week 12) weight-for-age z-score measurements. The model will adjust for randomization strata and assume, if estimable, an unstructured covariance structure. Least squares means at each visit and the estimated treatment effect and corresponding 95% confidence intervals and p-values will be reported from the model. The p-value will be evaluated against a two-sided 0.05 level of significance. Weight-for-age z-scores will be calculated using CDC reference equations [32]. Graphical displays will be used to show both unadjusted and adjusted mean changes in weight- for-age z-score between visits for the two treatment groups. Sensitivity analyses of the primary endpoint will include:  Performing the primary efficacy analysis on the per-protocol population.  Performing the primary efficacy analysis on the sub population of subjects determined to be pancreatic insufficient (defined as documented fecal elastase < 200 µg/g).  Missing data methods. Missing data sensitivity analyses of the primary endpoint will include the least favorable treatment arm imputation method, which imputes missing values with the mean change from the treatment arm with the worst change in the observed case analysis. Further details regarding missing data methods will be provided in the SAP. Additional sensitivity analyses of the primary endpoint may be performed to adjust for potential baseline confounders.
Sample 1
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Analysis of Primary Endpoint. Disease progression at 6 months All patients that receive trial treatment will be included in the analysis to determine the percentage of patients progressing by RECIST 1.1 criteria at 6 months when maintained on a combination regimen of paricalcitol plus pembrolizumab versus pembrolizumab alone. The 6-month time-point will be defined as 6 months (180 days) from the initial treatment (cycle 1/day 1). Statistical analysis will compare the proportion progression free at 6 months using a one-sided test of binomial proportions (equivalent to a Xxxxxxx’x xxx-squared test). If the assumptions of the Xxxxxxx'x xxx-squared test are not met, we will analyze the data using Xxxxxxx'x exact unconditional test of equality, as implemented in StatXact.20
Sample 1
Analysis of Primary Endpoint. The primary calculated endpoints for this trial are based on the percent weight loss at week 28, and the percentage of subjects with at least 5% weight loss at week 28. The percent weight loss at week 28 will be calculated as ***. The primary subject population is the Intent to Treat (ITT) population that consists of all subjects who are randomized, receive at least 1 dose of trial treatment, and have at least 1 post-dosing trial assessment. For subjects who discontinue treatment prior to trial completion, every attempt will be made to have them return to the clinic at week 28 for final assessments, regardless of when they discontinued trial treatment. For subjects who ***. The primary objective of the statistical test is to confirm that at least one of the proposed phentermine/topiramate combinations evaluated in this trial is an effective combination therapy *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. for weight reduction. To demonstrate that a combination therapy is effective, it is necessary to show that a *** versus each *** comprising the ***, and *** versus ***, are all significant at the *** using ***. If any one of the *** does not reach the *** level for either of the co-primary endpoints, then the efficacy of that combination cannot be confirmed. A step-down multiple testing procedure will be used to control the overall type I error for this trial. The hypothesis that the *** is an effective combination therapy will be tested first. Once the efficacy of this *** is confirmed, then the efficacy of the *** will be tested using the same criteria. Comparisons between treatments for the endpoint of percent weight loss will be assessed using a *** model with factors of ***. Comparisons between treatment of the percentage of subjects with at least 5% weight loss at week 28 will be evaluated by ***. Once the efficacy of both the *** has been confirmed, the difference in mean weight reduction between the *** therapies will be estimated. *** percent confidence intervals for the difference in mean percent body weight reduction between the two combination therapies will be derived.
Sample 1
Analysis of Primary Endpoint. ‌ The primary endpoint is the difference between treatment groups in the proportion of subjects with a 5% or greater relative change from baseline to Day 28 of FEV1 measured in liters, calculated as: (Day 28 FEV1 – Day 1 FEV1)*100 Day 1 FEV1 To test the null hypothesis that there is no difference between the treatment groups, a two-sample test of proportions will be performed adjusted for baseline FEV1 strata. The difference between treatment groups will be provided with associated 95% CI. Additional analyses of the relative change in FEV1 through Day 56 will include the development of a mixed-effect model for repeated measures (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 least square means (LSMeans) at Days 14, 28, and 56. Missing data methods will be described in the SAP.
Sample 1

Related to Analysis of Primary Endpoint

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

  • 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.

  • Analysis LICENSEE represents and agrees that it will only incorporate Components received from authorized suppliers into Licensed Products and for no other purpose, and that LICENSEE will not directly or indirectly attempt to reverse-engineer any material provided to it hereunder by LICENSEE or any supplier of any Component.

  • Sampling and Analysis The sampling and analysis of the coal shall be performed by Seller upon loading of the coal, and the results thereof shall be accepted and used as defining the quality and characteristics of the coal under this Agreement and as the Payment Analysis. All analyses shall be made in Seller’s laboratory at Seller’s expense in accordance with ASTM standards where applicable, or industry-accepted standards in other cases. Samples for analyses shall be taken in accordance with ASTM standards or other methods mutually acceptable to both parties. Seller shall transmit its quality analysis to Buyer as soon as possible. Each sample taken by Seller shall be divided into four (4) parts and put into airtight containers, properly labeled and sealed. One (1) part shall be used for analysis by Seller. One (1) part shall be used by Seller as a check sample, if Seller in its sole judgment determines it is necessary. One (1) part shall be retained by Seller until thirty (30) days after the sample is taken (“Disposal Date”), and shall be delivered to Buyer for analysis if Buyer so requests before the Disposal Date. One (1) part (the “Referee Sample”) shall be retained by Seller until the Disposal Date. Buyer, on reasonable notice to Seller, shall have the right to have a representative present to observe the sampling and analyses performed by Seller. Unless Buyer requests an analysis of the Referee Sample before the Disposal Date, Seller’s analysis shall be used to determine the quality of the coal under this Agreement and shall be the Payment Analysis. The Monthly Weighted Averages of specifications referenced in §6.1 shall be based on the individual Shipment analyses. If any dispute arises with regard to the analysis of any sample before the Disposal Date for such sample, the Referee Sample retained by Seller 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, if the analysis of the Independent Lab differs by more than the applicable ASTM reproducibility standards, the Independent Lab results will govern, and the prior analysis shall be disregarded. All testing of the Referee Sample by the Independent Lab shall be at requestor’s expense unless the Independent Lab results differ from the original Payment Analysis for any specification by more than the applicable ASTM reproducibility standards as to that specification. In such case, the cost of the analysis made by the Independent Lab shall be borne by the party who provided the original Payment Analysis.

  • Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X

  • Basis of Presentation In May 2020, the SEC adopted Release No. 33-10786 “Amendments to Financial Disclosures about Acquired and Disposed Businesses” (the “Final Rule”), which was effective on January 1, 2021. The pro forma financial statements and related notes are presented in accordance with the Final Rule. AAR has elected to present management’s adjustments in addition to transaction accounting adjustments in the pro forma financial statements. Transaction accounting adjustments are included in the preceding pro forma condensed combined financial information tables, while management’s adjustments are included only in note 5 within these notes to unaudited pro forma combined financial information Adjustments included in the “transaction accounting adjustments” column in the pro forma financial statements depict the accounting for the transaction required by GAAP. Transaction accounting adjustments reflect the application of required accounting principles to the transaction, applying the effects of the transaction to AAR’s historical financial information. Certain of the Product Support Business’s historical amounts have been reclassified to conform to AAR’s financial statement presentation, as discussed further in Note 3. The pro forma financial statements should be read in conjunction with (1) our unaudited consolidated financial statements and accompanying notes included in our Quarterly Report on Form 10-Q for the six months ended November 30, 2023 filed with the SEC on December 21 2023; (2) our audited consolidated financial statements and accompanying notes in our Annual Report on Form 10-K for the year ended May 31, 2023 as filed with the SEC on July 18, 2023; and (3) the Product Support Business’s historical audited combined financial statements as of and for the year ended March 31, 2023 and historical unaudited combined financial statements as of and for the nine months ended December 31, 2023 and accompanying notes, which are incorporated by reference as Exhibit 99.2 and Exhibit 99.4, respectively, to this Current Report on Form 8-K. In accordance with Accounting Standards Codification (“ASC”) 805, Business Combinations, the transaction will be accounted for using the acquisition method of accounting with AAR as the acquirer and the Product Support Business as the acquiree. Certain valuations and assessments, including valuations of property and equipment, identifiable intangible assets, assumed liabilities, and the associated income tax impacts are still in process. The estimated fair values used in the accompanying pro forma financial statements are preliminary and represent our current best estimate of fair value as of the date of filing but are subject to revision as valuations and assumptions are finalized. Changes in the fair values of the assets and liabilities between the preliminary estimates and final purchase accounting could have a material impact on the accompanying pro forma financial statements. In addition, the notes herein contain certain assumptions that could have a material impact on the accompanying pro forma financial statements.

  • Independent Analysis Each Party hereby confirms that its decision to execute this Agreement has been based upon its independent assessment of documents and information available to it, as it has deemed appropriate.

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