Analysis of Secondary Endpoints Sample Clauses

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.
Sample 1
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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.
Sample 1
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. *** 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.
Sample 1
Analysis of Secondary Endpoints. Secondary efficacy endpoints are: · The difference in absolute weight loss between randomization (baseline) 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. The difference in absolute weight reduction and the difference in waist reduction 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 5% and 10% body weight reduction from baseline to week 56 between treatment groups.
Sample 1
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:
Sample 1
Analysis of Secondary Endpoints 
Sample 1

Related to Analysis of Secondary Endpoints

  • 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.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company 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, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical 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.

  • 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.

  • Monitoring and Risk Assessment of Securities Depositories Prior to the placement of any assets of the Fund with a non-U.S. Securities Depository, the Custodian: (a) shall provide to the Fund or its authorized representative an assessment of the custody risks associated with maintaining assets within such Securities Depository; and (b) shall have established a system to monitor the custody risks associated with maintaining assets with such Securities Depository on a continuing basis and to promptly notify the Fund or its Investment Adviser of any material changes in such risk. In performing its duties under this subsection, the Custodian shall use reasonable care and may rely on such reasonable sources of information as may be available including but not limited to: (i) published ratings; (ii) information supplied by a Subcustodian that is a participant in such Securities Depository; (iii) industry surveys or publications; (iv) information supplied by the depository itself, by its auditors (internal or external) or by the relevant Foreign Financial Regulatory Authority. It is acknowledged that information procured through some or all of these sources may not be independently verifiable by the Custodian and that direct access to Securities Depositories is limited under most circumstances. Accordingly, the Custodian shall not be responsible for errors or omissions in its duties hereunder provided that it has performed its monitoring and assessment duties with reasonable care. The risk assessment shall be provided to the Fund or its Investment Advisor by such means as the Custodian shall reasonably establish. Advices of material change in such assessment may be provided by the Custodian in the manner established as customary between the Fund and the Custodian for transmission of material market information.

  • Testing Landlord shall have the right to conduct annual tests of the Premises to determine whether any contamination of the Premises or the Project has occurred as a result of Tenant’s use. Tenant shall be required to pay the cost of such annual test of the Premises; provided, however, that if Tenant conducts its own tests of the Premises using third party contractors and test procedures acceptable to Landlord which tests are certified to Landlord, Landlord shall accept such tests in lieu of the annual tests to be paid for by Tenant. In addition, at any time, and from time to time, prior to the expiration or earlier termination of the Term, Landlord shall have the right to conduct appropriate tests of the Premises and the Project to determine if contamination has occurred as a result of Tenant’s use of the Premises. In connection with such testing, upon the request of Landlord, Tenant shall deliver to Landlord or its consultant such non-proprietary information concerning the use of Hazardous Materials in or about the Premises by Tenant or any Tenant Party. If contamination has occurred for which Tenant is liable under this Section 30, Tenant shall pay all costs to conduct such tests. If no such contamination is found, Landlord shall pay the costs of such tests (which shall not constitute an Operating Expense). Landlord shall provide Tenant with a copy of all third party, non-confidential reports and tests of the Premises made by or on behalf of Landlord during the Term without representation or warranty and subject to a confidentiality agreement. Tenant shall, at its sole cost and expense, promptly and satisfactorily remediate any environmental conditions identified by such testing in accordance with all Environmental Requirements. Landlord’s receipt of or satisfaction with any environmental assessment in no way waives any rights which Landlord may have against Tenant.

  • Product Testing Upon request, Customer shall provide Operator a laboratory report for each Product delivery by Customer or Customer’s supplier. Operator will not be obligated to receive Contaminated Product for throughput across the Berths, nor will Operator be obligated to accept Product that fails to meet the quality specifications set forth in the arrival notice.

  • 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.

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