Populations for Analyses Sample Clauses

Populations for Analyses. ‌‌ The analysis populations will consist of subjects as defined below: • The Screened Analysis Set includes all subjects who are screened for the study. This population is used primarily for subject accounting purposes and will generally not be used for summary or analysis. • The Randomized Set includes all subjects who are randomized to receive study drug regardless of whether they take a dose. • The Safety Analysis Set includes all subjects who receive at least one dose of study drug. Subjects will be classified according to the treatment they actually receive. • The Full Analysis Set (FAS) includes all randomized IBS-D and IBS-M subjects who took at least one dose of double-blind study drug and had a baseline diary assessment and at least 1 post -randomization diary entry. Subjects will be analyzed according to randomized treatment, irrespective of whether or not they have prematurely discontinued, according to the Intent -to-Treat principle. The Full Analysis Set for IBS-D (FAS-D) and Full Analysis Set for IBS-M (FAS-M) are each a subset of FAS and consists of IBS-D and IBS-M subjects, respectively. The FAS-D will serve as the primary population for the primary analysis of efficacy data in this study. • The Per-Protocol Set for IBS-D excludes subjects from the FAS-D due to important deviations from the protocol that may substantially affect the result of the primary efficacy endpoint (ie, Major Protocol Deviations associated with efficacy). The Per -Protocol Set will serve as the supportive population for the analysis of efficacy data in this study. Other Per- Protocol Sets may be defined.
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Populations for Analyses. The following analysis populations are planned: Analysis Set Definition Full Analysis Set All subjects who are randomized. Subjects will be classified according to the treatment assigned at randomization. The Full Analysis Set will be the primary population for evaluating all efficacy endpoints and subject characteristics. Per-protocol Analysis Set A subset of the Full Analysis Set and will include subjects who receive at least 1 dose of study treatment and do not have major protocol deviations expected to impact the primary objective of the study. Major protocol deviations will be pre-specified in the SAP. The Per-protocol Analysis Set will be used for sensitivity analyses for the primary efficacy endpoint. Safety Analysis Set All subjects who receive at least 1 dose of study treatment. Subjects will be classified according to the treatment assigned at randomization unless the incorrect treatment(s) are received throughout the dosing period, in which case subjects will be classified according to the first treatment received. The Safety Analysis Set will be the primary population for evaluating treatment administration/compliance and safety. PK Analysis Set All treated subjects who have at least 1 concentration above the limit of quantitation of the study treatment in RIST4721 arm only.
Populations for Analyses. ‌ The following study populations are defined and will be analyzed as specified below. All evaluable patients fit into the Safety dataset, among other datasets: The Intent to Treat (ITT) dataset: the total population of patients registered in the study. Safety dataset: all registered participants who received at least one Chemoplaque study intervention. Efficacy population: all enrolled patients who completed 42 days with at least one Chemoplaque and had adequate assessment of disease progression. Any patient who is registered on to this trial but never receives study treatment will be described, including the reason(s) for non-participation. All patients that receive a study dose will be included in all analyses. Any patient who is registered but never receives study treatment will be described, including the reason(s) for non-participation.

Related to Populations for Analyses

  • Data Analysis In the meeting, the analysis that has led the College President to conclude that a reduction- in-force in the FSA at that College may be necessary will be shared. The analysis will include but is not limited to the following: ● Relationship of the FSA to the mission, vision, values, and strategic plan of the College and district ● External requirement for the services provided by the FSA such as accreditation or intergovernmental agreements ● Annual instructional load (as applicable) ● Percentage of annual instructional load taught by Residential Faculty (as applicable) ● Fall Full-Time Student Equivalent (FFTE) inclusive of dual enrollment ● Number of Residential Faculty teaching/working in the FSA ● Number of Residential Faculty whose primary FSA is the FSA being analyzed ● Revenue trends over five years for the FSA including but not limited to tuition and fees ● Expenditure trends over five years for the FSA including but not limited to personnel and capital ● Account balances for any fees accounts within the FSA ● Cost/benefit analysis of reducing all non-Residential Faculty plus one Residential Faculty within the FSA ● An explanation of the problem that reducing the number of faculty in the FSA would solve ● The list of potential Residential Faculty that are at risk of layoff as determined by the Vice Chancellor of Human Resources ● Other relevant information, as requested

  • Technology Research Analyst Job# 1810 General Characteristics Maintains a strong understanding of the enterprise’s IT systems and architectures. Assists in the analysis of the requirements for the enterprise and applying emerging technologies to support long-term business objectives. Responsible for researching, collecting, and disseminating information on emerging technologies and key learnings throughout the enterprise. Researches and recommends changes to foundation architecture. Supports research projects to identify and evaluate emerging technologies. Interfaces with users and staff to evaluate possible implementation of the new technology in the enterprise, consistent with the goal of improving existing systems and technologies and in meeting the needs of the business. Analyzes and researches process of deployment and assists in this process.

  • Additional Information for Product Development Projects Outcome of product development efforts, such copyrights and license agreements. • Units sold or projected to be sold in California and outside of California. • Total annual sales or projected annual sales (in dollars) of products developed under the Agreement. • Investment dollars/follow-on private funding as a result of Energy Commission funding. • Patent numbers and applications, along with dates and brief descriptions.  Additional Information for Product Demonstrations: • Outcome of demonstrations and status of technology. • Number of similar installations. • Jobs created/retained as a result of the Agreement.

  • 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 Analysis 31 F-tests and t-tests will be used to analyze OV and Quality Acceptance data. The F-test is a 32 comparison of variances to determine if the OV and Quality Acceptance population variances 33 are equal. The t-test is a comparison of means to determine if the OV and Quality Acceptance 34 population means are equal. In addition to these two types of analyses, independent verification 35 and observation verification will also be used to validate the Quality Acceptance test results.

  • Solicitations for Subcontractors, Including Procurements of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the contractor for work to be performed under a subcontract, including procurements of materials or leases of equipment, each potential subcontractor or supplier shall be notified by the contractor of the contractor's obligations under this contract and the Regulations relative to nondiscrimination on the grounds of race, color, or national origin, sex, age, and disability/handicap.

  • Solicitations for Subcontracts, Including Procurements of Materials and Equipment In all solicitations either by competitive bidding or negotiation made by the Engineer for work to be performed under a subcontract, including procurements of materials or leases of equipment, each potential subcontractor or supplier shall be notified by the Engineer of the Engineer's obligations under this contract and the Regulations relative to nondiscrimination on the grounds of race, color, or national origin.

  • For Product Development Projects and Project Demonstrations  Published documents, including date, title, and periodical name.  Estimated or actual energy and cost savings, and estimated statewide energy savings once market potential has been realized. Identify all assumptions used in the estimates.  Greenhouse gas and criteria emissions reductions.  Other non-energy benefits such as reliability, public safety, lower operational cost, environmental improvement, indoor environmental quality, and societal benefits.  Data on potential job creation, market potential, economic development, and increased state revenue as a result of the project.  A discussion of project product downloads from websites, and publications in technical journals.  A comparison of project expectations and performance. Discuss whether the goals and objectives of the Agreement have been met and what improvements are needed, if any.

  • COVID-19 Protocols Contractor will abide by all applicable COVID-19 protocols set forth in the District’s Reopening and COVID-19 Mitigation Plan and the safety guidelines for COVID-19 prevention established by the California Department of Public Health and the Ventura County Department of Public Health.

  • 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.

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