Analysis Populations Sample Clauses

Analysis Populations. Intent-to-treat (ITT) and safety populations: All subjects who are randomized, take one or more doses and have at least one post dosing assessment will be included in the ITT and safety populations.
Sample 1
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Analysis Populations. The Safety Population will include all subjects who receive at least 1 dose of study drug. The PK Population will include subjects who receive study drug and have sufficient concentration data to facilitate the calculation of PK variables.
Sample 1
Analysis Populations. The population valid for the safety analysis will be comprised of all patients who received treatment with IRE. Patients who received at least one treatment with IRE will be valid for safety analysis.
Sample 1
Analysis Populations. The following analysis populations will be used:
Sample 1
Analysis Populations. The Total Population will comprise all subjects screened and for whom a record exists on the study database. The Safety population will consist of all subjects who were randomised to treatment and who received at least one dose of trial medication. Randomised subjects will be assumed to have received trial medication unless definitive evidence exists to the contrary. If any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they took for the majority (i.e. >50%) of the treatment period. This population will form the primary population for analyses of safety data The Intent-to-Treat – Efficacy (ITT) population will consist of all subjects in the Safety Population, with the exception of subjects recruited at sites which were closed down as the result of audit findings or other information which implied that the integrity of the data had been compromised. These subjects will be excluded from the ITT population (and all efficacy analyses), and this decision will be formally documented prior to unblinding of the trial.. The ITT Population follows the intention-to-treat principles defined in the ICH E9 guidelines [The European Agency for the Evaluation of Medicinal Products, 1998]. Following these principles, if any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they were originally randomised, irrespective of which treatment they actually took. This population will form the primary population for analysis of efficacy measures, including mortality, and for analyses of health outcomes measures. The Health Outcomes Population will be a subset of the Intent-to-Treat – Efficacy Population, and will consist of subjects participating in countries where SGRQ questionnaire translations are linguistically valid for the population, and who have completed at least one questionnaire. If any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they were originally randomised, irrespective of which treatment they actually took. This population will be used for all analyses and listings pertaining to health outcomes related to ...
Sample 1
Analysis Populations. ‌ Three different analysis populations will be used for analysis of data from this study, as described below: • Randomized: This population will be comprised of all subjects who were initially randomized. This population will be used for summaries of subject disposition and baseline subject characteristics. • Intent-to-treat (ITT)/Safety: This population will be comprised of all subjects who were initially randomized and received at least one dose of study drug. This will be the primary population for all summaries of subject disposition and baseline characteristics, efficacy analyses, and safety analyses for purposes of regulatory submissions. • Modified Intent-to Treat (m-ITT): This population will be comprised of all randomized study subjects who receive study treatment and return for at least one post-randomization assessment of height and weight. This population will be used for the analysis of all efficacy variables for all other purposes, including but not limited to publications, presentations, and robustness of sensitivity of analyses.
Sample 1

Related to Analysis Populations

  • Population The Population shall be defined as all Paid Claims during the 12-month period covered by the Claims Review.

  • 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.

  • 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).

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.‌ b. A description or identification of the statistical sampling software package used by the IRO.‌

  • 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.”

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • TECHNICAL EVALUATION (a) Detailed technical evaluation shall be carried out by Purchase Committee pursuant to conditions in the tender document to determine the substantial responsiveness of each tender. For this clause, the substantially responsive bid is one that conforms to all the eligibility and terms and condition of the tender without any material deviation. The Institute’s determination of bid’s responsiveness is to be based on the contents of the bid itself without recourse to extrinsic evidence. The Institute shall evaluate the technical bids also to determine whether they are complete, whether required sureties have been furnished, whether the documents have been properly signed and whether the bids are in order. (b) The technical evaluation committee may call the responsive bidders for discussion or presentation to facilitate and assess their understanding of the scope of work and its execution. However, the committee shall have sole discretion to call for discussion / presentation. (c) Financial bids of only those bidders who qualify the technical criteria will be opened provided all other requirements are fulfilled. (d) AIIMS Jodhpur shall have right to accept or reject any or all tenders without assigning any reasons thereof.

  • 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.

  • Target Population TREATMENT FOR ADULT (TRA) Target Population

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