Primary Efficacy Analysis Sample Clauses

The Primary Efficacy Analysis clause defines the main method by which the effectiveness of a treatment or intervention will be evaluated in a clinical study. Typically, this clause specifies the primary endpoint, the statistical approach to be used, and the population included in the analysis, such as the intent-to-treat group. By clearly outlining these parameters, the clause ensures that all parties understand how success will be measured, thereby providing a transparent and objective basis for assessing the study's outcomes and supporting regulatory or scientific conclusions.
Primary Efficacy Analysis. The primary efficacy endpoint is the responder rate for lip fullness on the LFS2, which is defined as the proportion of subjects who show ≥ 1-point improvement on the LFS2 compared to baseline assessment, at Day 30 after last treatment received.
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Primary Efficacy Analysis. 11.5.1.1. Progression-Free Survival
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Primary Efficacy Analysis. The efficacy evaluation will be based on the full analysis set, which will include all patients who receive at least 1 dose of study drug. The statistical method to be used for the SRI is the logistic regression model with treatment and stratification factors as main factors. Patients who withdraw from the study are classified as nonresponders as measured by SRI at week 52 in the primary analysis. The SRI is linked to the model factors through the logit function. The likelihood-ratio–based Chi-square statistics will be used for testing the treatment difference between IPP-201101 and placebo in SRI at week 52 at the significance level 0.05. The odds ratio (active/placebo) and associated 95% confidence interval will be determined from the logistic regression model. As sensitivity analyses, the primary analysis will be repeated using another 3 imputation methods to estimate missing SRI at week 52 according to the reason for withdrawal. In the 1st method, patients who withdraw because of lack of efficacy will be classified as treatment failures assessed by SRI at week 52. For patients who withdraw because of other reasons, their missing SRI at week 52 will be estimated using the multiple imputation method (▇▇▇▇▇▇ and ▇▇▇▇▇, 2002). The imputation values will be drawn from the categories formed by treatment group and randomization stratum to which the patient belongs. In the 2nd method, the missing SRI at week 52 will be imputed using the last observation carried forward (LOCF) method. In the 3rd method, patients who withdraw and those completers who used prohibited medication within 8 weeks from week 52 will be classified as nonresponders.
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Primary Efficacy Analysis. Response efficacy endpoints from Week 1 through Week 12 will be analyzed using the ▇▇▇▇▇▇▇ -▇▇▇▇▇▇-Haenszel risk difference estimate. The estimated difference in the proportion of responders and 90% confidence interval for the difference will be calculated using the ▇▇▇▇▇▇▇ -▇▇▇▇▇▇-Haenszel risk difference estimate stratified by baseline abdominal pain (< 6 vs ≥ 6) with weights proposed by Greenland and Robins. For the analysis of other continuous endpoints (eg, change from baseline at Week 12), a mixed model for repeated measures with restricted maximum likelihood estimation will be used by incorporating on treatment- values at all time points. The analysis model for the efficacy endpoint will include terms for treatment, visit, baseline score, and interaction of visit by treatment. An unstructured covariance matrix will be used to model the correlation among repeated measurements. The ▇▇▇▇▇▇▇-▇▇▇▇▇ adjustment for denominator degrees of freedom will be used with restricted (or residual) maximum likelihood to make statistical inference. Further details will be provided in the SAP.
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Primary Efficacy Analysis 
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Related to Primary 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 sampling and analysis of the coal delivered hereunder shall be performed by Buyer upon delivery of the coal to Buyer’s facility, and the results thereof shall be accepted and used as defining the quality and characteristics of the coal delivered under this Agreement and as the Payment Analysis. All analyses shall be made in Buyer’s laboratory at Buyer’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 “as loaded” quality analysis to Buyer as soon as possible. Seller’s “as-loaded” quality shall be the Payment Analysis only when Buyer’s sampler and/or scales are inoperable, or if Buyer fails to obtain a sample upon unloading. Seller represents that it is familiar with Buyer’s sampling and analysis practices, and that it 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 industry-accepted changes in practices, provide for no less accuracy than the sampling and analysis practices existing at the tune of the execution of this Agreement, unless the Parties otherwise mutually agree. Each sample taken by Buyer 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 Buyer. One (1) 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 until thirty (30) days after the sample is taken (“Disposal Date”), and shall be delivered to Seller for analysis if Seller so requests before the Disposal Date. One (1) part (the “Referee Sample”) shall be retained by Buyer until the Disposal Date. Seller shall be given copies of all analyses made by Buyer by the fifth (5th) business day of the month following the month of unloading. In addition, Buyer shall send Seller weekly analyses of coal unloaded at Buyer’s facilities. 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 an analysis of the Referee Sample before the Disposal Date, Buyer’s analysis shall be used to determine the quality of the coal delivered hereunder 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 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, 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.

  • 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;

  • 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.