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Efficacy Analysis Sample Clauses

Efficacy Analysis. 9.2.1. Analysis of Primary Endpoints *** 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.
Efficacy Analysis. A test for country-by-treatment interaction with respect to the primary efficacy endpoint, percent change from baseline in hepatic fat fraction at Week 12, as determined by MRI-PDFF, will be performed in the 50 mg cohort. An ANCOVA model with fixed effects for the stratification factor (diabetes presence/absence), country (US/China), treatment group (TVB-2640 50 mg and pooled placebo), and country-by-treatment interaction and with the baseline MRI-PDFF value as a covariate including all subjects from US and China will be performed. If there is no interaction detected (p≥0.05), the primary efficacy endpoint, percent change from baseline in hepatic fat fraction at Week 12, as determined by MRI PDFF, will be analyzed using an analysis of covariance (ANCOVA) model with fixed effects for the stratification factor (diabetes presence/absence) and treatment group (i.e., randomized TVB-2640 dose groups and pooled placebo) and with the baseline MRI-PDFF value as a covariate including all subjects from US and China. If the country-by-treatment interaction is significant (p<0.05) then the primary analysis will be conducted on subjects enrolled in the US and will maintain sufficient power with the 90 evaluable subjects in the US (30 active in each cohort and 30 combined placebo). A separate analysis would be performed on subjects enrolled in China in the 50 mg cohort. This analysis is not powered to detect a significant difference but would be supportive/descriptive in nature to evaluate trends. The primary efficacy analyses will be based on a F-test from the ANCOVA model in the mITT to compare each randomized TVB-2640 dose group individually with the placebo group. The fixed-sequence method, as described below, will be used to maintain an overall 0.05 Type I error rate. Data normality will be assessed and the appropriate data transformation will be applied to fulfill the underlying assumption of the ANCOVA model; if a suitable transformation cannot be determined the corresponding rank ANCOVA will become the primary analysis for this endpoint. Treatment interaction will be evaluated among the treatment groups, and if needed it will be considered supportive of the primary efficacy analyses. Summary statistics will be displayed by treatment group along with the difference in least squares means (and the associated 95% confidence interval and p-value) for each randomized TVB-2640 dose group to pooled placebo comparison. Differences between each randomized TVB-2640 dose gr...
Efficacy AnalysisThe primary analysis of efficacy will be based on the evaluable treated subjects, hence, only those subjects who received a complete or partial study treatment and completed a follow-up visit at 30-days post-treatment #2 will be included in the analysis using the Last Value Carried Forward method. Analyses of safety will include all subjects who received (complete or incomplete) study treatment. Efficacy will be the proportion of treated subjects determined to be improved by the reduction in the number of sweat glands from baseline to 30-days post-treatment #2.
Efficacy Analysis. 4.4.1 Primary Efficacy Variable The primary end-point, that is, the proportion achieving “smoking reduction” at 24 weeks, will be analyzed with logistic regression modeling among eligible subjects using intent-to treat criteria and with participants who terminated the study prematurely for any reason considered to be failures.
Efficacy Analysis. Efficacy evaluation will be based on the full analysis set (see section 10.3) that includes all patients who received at least 1 dose of the study drug.
Efficacy Analysis. The estimand for the primary efficacy analysis is defined as follows: 1. The treatment regimen for participants is: placebo or SAGE-217 for 14 days. 2. The target population is adult participants with a diagnosis with severe PPD (baseline HAM-D total score ≥26). 3. The variable of interest is the change from baseline in HAM-D total score at Day 15. 4. The population summary level deals with the difference between SAGE-217 and placebo treatments in mean change from baseline in HAM-D total score at Day 15. 5. The intercurrent events could be: a. The premature discontinuation of treatment for any reason, thus not having a Day 15 HAM-D total score available. This will be handled by a sensitivity analysis using multiple imputation technique (details will be provided in the SAP). b. Certain medications including, but not limited to, new antidepressants or benzodiazepines are prohibited in the protocol until Day 45 follow-up; however, the treatment policy strategy dictates that the results following these prohibited medication use will not be manipulated, but will rather be used ‘as is’ in analysis. Please note that this protocol does not specify any rescue medication, hence there is no rescue medication to be considered. Data will be analyzed using a mixed-effects model for repeated measures (MMRM); the model will include treatment, baseline HAM-D total score, stratification factor, assessment time point, and time point-by-treatment as explanatory variables. All explanatory variables will be treated as fixed effects. All postbaseline time points will be included in the model. Model-based point estimates (ie, least squares means, 95% confidence intervals, and p values) will be reported where applicable. An unstructured covariance structure will be used to model the within- participant errors. If there is a convergence issue with the unstructured covariance model, Toeplitz compound symmetry or Autoregressive (1) [AR(1)] covariance structure will be used, following this sequence until convergence is achieved. If the model still does not converge with AR(1) structure, no results will be reported. When the covariance structure is not UN, the sandwich estimator for the variance covariance matrix will be derived, using the EMPIRICAL option in the PROC MIXED statement in SAS. Similar to those methods described above for the primary endpoint, an MMRM will be used for the analysis of the change from baseline in other time points in HAM-D total score, MADRS total score, HA...
Efficacy Analysis. The key secondary endpoint, proportion of subjects achieving HiSCR50 at Week 12, will be analyzed using Xxxxxx’x exact test. Proportions and difference in proportions between treatment groups, and their associated 95% confidence intervals (CIs) will be reported. For subjects who discontinue study treatment prior to Week 12 due to any reason, their last observation will be used to impute response status. Xxxxxx’x exact test will also be used to analyze additional secondary endpoints which are dichotomized in nature, eg, proportion of subjects achieving HiSCR75 at Week 12, proportion of subjects with flare by Week 12, and other proportion endpoints. Change from baseline in NRS skin pain score, change from baseline in IHS4, and other continuous endpoints will be summarized using descriptive statistics. Change from baseline of these continuous endpoints will also be analyzed by a Mixed-effects model for repeated measures (MMRM). MMRM will include baseline as a covariate, treatment and visit as factors, and treatment-by-visit and baseline-by-visit interactions in the model.

Related to Efficacy Analysis

  • 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.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • 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.

  • Escrow Analysis If applicable, with respect to each Mortgage Loan, the Seller has within the last twelve months (unless such Mortgage was originated within such twelve month period) analyzed the required Escrow Payments for each Mortgage and adjusted the amount of such payments so that, assuming all required payments are timely made, any deficiency will be eliminated on or before the first anniversary of such analysis, or any overage will be refunded to the Mortgagor, in accordance with RESPA and any other applicable law;

  • Technology Research Analyst Job# 1810 General Characteristics

  • Research Analyst Independence The Company acknowledges that the Underwriters’ research analysts and research departments are required to be independent from their respective investment banking divisions and are subject to certain regulations and internal policies, and that such Underwriters’ research analysts may hold views and make statements or investment recommendations and/or publish research reports with respect to the Company and/or the offering that differ from the views of their respective investment banking divisions. The Company hereby waives and releases, to the fullest extent permitted by law, any claims that the Company may have against the Underwriters with respect to any conflict of interest that may arise from the fact that the views expressed by their independent research analysts and research departments may be different from or inconsistent with the views or advice communicated to the Company by such Underwriters’ investment banking divisions. The Company acknowledges that each of the Underwriters is a full service securities firm and as such from time to time, subject to applicable securities laws, may effect transactions for its own account or the account of its customers and hold long or short positions in debt or equity securities of the companies that may be the subject of the transactions contemplated by this Agreement.

  • 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.

  • 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.

  • Investment Analysis and Commentary The Subadviser will provide quarterly performance analysis and market commentary (the “Investment Report”) during the term of this Agreement. The Investment Reports are due within 10 days after the end of each quarter. In addition, interim Investment Reports shall be issued at such times as may be mutually agreed upon by the Adviser and Subadviser; provided however, that any such interim Investment Report will be due within 10 days of the end of the month in which such agreement is reached between the Adviser and Subadviser. The subject of each Investment Report shall be mutually agreed upon. The Adviser is freely able to publicly distribute the Investment Report.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.