Study Objectives and Endpoints Sample Clauses

Study Objectives and Endpoints. ‌ This study considers the primary efficacy endpoint as well as secondary efficacy and safety endpoints for which labeling claims based on hypothesis tests are desired (see listed in Table below). The trial will be considered a success if the primary hypothesis is met for both the PP and ITT sets (details are provided in Table 3 below). Below is the list of primary and secondary endpoints: Table 3: Primary and secondary objectives and endpoints Objective Endpoint Primary 1 To compare the improvement in pain following groin hernia repair by LiquiBand FIX8® to control device as measured by Visual Analog Scale (VAS) at baseline (worst pain experienced within 1 month of screening visit) and at six months post hernia repair. Effectiveness of LiquiBand FIX8® will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and XXXX) hernia repair. Success will be determined by improvement in pain not inferior to control device as measured by a VAS value (0 = no pain to 10 = most pain imaginable) from baseline (worst pain experienced within 1 month of screening visit) to six months post hernia repair. Secondary 1 To evaluate the incidence of hernia recurrence in patients following laparoscopic (TEP and XXXX) hernia repair using LiquiBand FIX8® or control device. The incidence of hernia recurrence in patients following laparoscopic (TEP and XXXX) groin hernia repair by LiquiBand FIX8® or control (AbsorbaTack™) will be assessed by physical examination at 2 weeks, 3 months, and 6 months. Suspected hernia recurrence will also be evaluated at any time following surgery and up to the 12 month follow up visit if reported by the subject. Suspected hernia recurrence will be confirmed by ultrasound imaging following physical examination. Secondary 2 To compare the use of LiquiBand FIX8® to control device for mesh fixation at time of surgery. LiquiBand FIX8® will be required to successfully fix hernia mesh in patients undergoing TEP and XXXX laparoscopic groin hernia repair, at a rate non-inferior to control device (AbsorbaTack™) in order to meet this end point. Successful mesh fixation would not require any additional fixation by alternate fixation device. Unsuccessful mesh fixation is defined as requiring the use of an alternative fixation device or additional procedure to achieve adequate fixation. Secondary 3 To compare the use of LiquiBand FIX8® to control devices for the approximation of the peritoneum (XXXX repairs only) at time of ...
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Study Objectives and Endpoints 

Related to Study Objectives and Endpoints

  • Objectives and Scope 1. The Parties confirm their joint objective of strengthening and deepening their relations in all fields covered by this Agreement by developing their political dialogue and reinforcing their co-operation. 2. The Parties confirm their joint objective of working towards creating conditions under which, building on the outcome of the Doha Work Programme, a feasible and mutually beneficial Association Agreement, including a Free Trade Agreement, could be negotiated between them. 3. Implementation of this Agreement should help to create these conditions by striving for political and social stability, deepening the regional integration process and reducing poverty within a sustainable development framework in the Andean Community. 4. This Agreement governs the political dialogue and co-operation between the Parties and contains the necessary institutional arrangements for its application. 5. The Parties undertake to periodically assess progress, taking account of progress achieved before the entry into force of the Agreement.

  • Scope and Objectives 1. This Partnership Agreement (hereinafter referred to as the “Agreement”) defines the rights and obligations of the Parties and sets forth the terms and conditions of their cooperation in the implementation of the Project. 2. The Parties shall act in accordance with the legal framework of the EEA Financial Mechanism 2014-2021, namely with the Regulation on the implementation of the EEA Financial Mechanism 2014-2021 (hereinafter referred to as the “Regulation”). The Parties expressly acknowledge to have access to and to be familiar with the content of the Regulation. 3. Any Annexes to this Agreement constitute an integral part of the Agreement. In case of inconsistencies between the Annexes and the Agreement, the latter shall prevail.

  • Project Objectives 1.1 (Type the Project objectives)

  • Program Objectives Implement a rigorous constructability program following The University of Texas System, Office of Facilities Planning and Construction Constructability Manual. Identify and document project cost and schedule savings (targeted costs are 5% of construction costs). Clarification of project goals, objectives.

  • Targets and Milestones You may choose to develop specific additional targets and milestones which assess your performance in ITT over time – particularly if ITT trainees make up a significant proportion of your overall student body. Alternatively, you may have targets and milestones in your existing 2012-13 access agreement which you now also wish to apply to undergraduate and/or postgraduate ITT trainees. These targets may be statistical – based on how representative your entrants are and/or your retention performance – and might include annual or interim milestones to help you monitor whether you are making progress. You may wish to include criteria around the numbers of trainees in receipt of a full or partial maintenance grant, as financial data will need to be collected to determine bursary support and the data will also be accessible through the Student Loans Company for HEBSS subscribers. You may also wish to consider the TDA guidance at Annex C which gives information on specific groups that are underrepresented in the teaching profession.

  • Goals and Objectives The purpose of this Agreement is to ensure that the proper elements and commitments are in place to provide consistent service support and delivery to the customers by the Service Providers. The goal of this Agreement is to obtain mutual agreement for the provision of information and communication between the Service Provider and customer. The objective of this Agreement is to: • Provide clear reference to service ownership, accountability, roles and responsibilities. • Present clear, concise and measurable description of service provision to the customer. • Match perceptions of the expected service provision with actual service support and delivery.

  • Project/Milestones Taxpayer provides refrigerated warehousing and logistic distribution services to clients throughout the United States. In consideration for the Credit, Taxpayer agrees to invest in a new refrigeration and distribution facility in the XxXxxxxxx Park area of Sacramento, California, and hire full-time employees (collectively, the “Project”). Further, Taxpayer agrees to satisfy the milestones as described in Exhibit A (“Milestones”) and must maintain Milestones for a minimum of three (3) taxable years thereafter. In the event Taxpayer employs more than the number of full-time employees, determined on an annual full-time equivalent basis, than required in Exhibit A, for purposes of satisfying the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” Taxpayer may use the salaries of any of the full-time employees hired within the required time period. For purposes of calculating the “Minimum Annual Salary of California Full-time Employees Hired” and the “Cumulative Average Annual Salary of California Full-time Employees Hired,” the salary of any full-time employee that is not employed by Taxpayer for the entire taxable year shall be annualized. In addition, the salary of any full-time employee hired to fill a vacated position in which a full-time employee was employed during Taxpayer’s Base Year shall be disregarded.

  • Goals and Objectives of the Agreement Agreement Goals The goals of this Agreement are to: ● Reduce wildfire risk related to the tree mortality crisis; ● Provide a financial model for funding and scaling proactive forestry management and wildfire remediation; ● Produce renewable bioenergy to spur uptake of tariffs in support of Senate Bill 1122 Bio Market Agreement Tariff (BioMat) for renewable bioenergy projects, and to meet California’s other statutory energy goals; ● Create clean energy jobs throughout the state; ● Reduce energy costs by generating cheap net-metered energy; ● Accelerate the deployment of distributed biomass gasification in California; and ● Mitigate climate change through the avoidance of conventional energy generation and the sequestration of fixed carbon from biomass waste. Ratepayer Benefits:2 This Agreement will result in the ratepayer benefits of greater electricity reliability, lower costs, and increased safety by creating a strong market demand for forestry biomass waste and generating cheap energy. This demand will increase safety by creating an economic driver to support forest thinning, thus reducing the risk of catastrophic wildfire and the associated damage to investor-owned utility (IOU) infrastructure, such as transmission lines and remote substations. Preventing this damage to or destruction of ratepayer-supported infrastructure lowers costs for ratepayers. Additionally, the ability of IOUs to use a higher- capacity Powertainer provides a much larger offset against the yearly billion-dollar vegetation management costs borne by IOUs (and hence by ratepayers). The PT+’s significant increase in waste processing capacity also significantly speeds up and improves the economics of wildfire risk reduction, magnifying the benefits listed above. The PT+ will directly increase PG&E’s grid reliability by reducing peak loading by up to 250 kilowatt (kW), and has the potential to increase grid reliability significantly when deployed at scale. The technology will provide on-demand, non- weather dependent, renewable energy. The uniquely flexible nature of this energy will offer grid managers new tools to enhance grid stability and reliability. The technology can be used to provide local capacity in hard-to-serve areas, while reducing peak demand. Technological Advancement and Breakthroughs:3 This Agreement will lead to technological advancement and breakthroughs to overcome barriers to the achievement of California’s statutory energy goals by substantially reducing the LCOE of distributed gasification, helping drive uptake of the undersubscribed BioMAT program and increasing the potential for mass commercial deployment of distributed biomass gasification technology, particularly through net energy metering. This breakthrough will help California achieve its goal of developing bioenergy markets (Bioenergy Action Plan 2012) and fulfil its ambitious renewable portfolio standard (SB X1-2, 2011-2012; SB350, 2015). The PT+ will also help overcome barriers to achieving California’s greenhouse gas (GHG) emissions reduction (AB 32, 2006) and air quality improvement goals. It reduces greenhouse gas and criteria pollutants over three primary pathways: 1) The PT+’s increased capacity and Combined Heat and Power (CHP) module expand the displacement of emissions from conventional generation; 2) the biochar offtake enables the sequestration of hundreds of tons carbon that would otherwise have been released into the atmosphere; and 3) its increased processing capacity avoids GHG and criteria emissions by reducing the risk of GHG emissions from wildfire and other forms of disposal, such as open pile burning or decomposition. The carbon sequestration potential of the biochar offtake is particularly groundbreaking because very few technologies exist that can essentially sequester atmospheric carbon, which is what the PT+ enables when paired with the natural forest ecosystem––an innovative and groundbreaking bio-energy technology, with carbon capture and storage. Additionally, as noted in the Governor’s Clean Energy Jobs Plan (2011), clean energy jobs are a critical component of 2 California Public Resources Code, Section 25711.5(a) requires projects funded by the Electric Program Investment Charge (EPIC) to result in ratepayer benefits. The California Public Utilities Commission, which established the EPIC in 2011, defines ratepayer benefits as greater reliability, lower costs, and increased safety (See CPUC “Phase 2” Decision 00-00-000 at page 19, May 24, 2012, xxxx://xxxx.xxxx.xx.xxx/PublishedDocs/WORD_PDF/FINAL_DECISION/167664.PDF). 3 California Public Resources Code, Section 25711.5(a) also requires EPIC-funded projects to lead to technological advancement and breakthroughs to overcome barriers that prevent the achievement of the state’s statutory and energy goals. California’s energy goals. When deployed at scale, the PT+ will result in the creation of thousands of jobs across multiple sectors, including manufacturing, feedstock supply chain (harvesting, processing, and transportation), equipment operation, construction, and project development. ● Annual electricity and thermal savings; ● Expansion of forestry waste markets; ● Expansion/development of an agricultural biochar market; ● Peak load reduction; ● Flexible generation; ● Energy cost reductions; ● Reduced wildfire risk; ● Local air quality benefits; ● Water use reductions (through energy savings); and ● Watershed benefits.

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving (either itself or through the acts of a SUBLICENSEE) the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • 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).

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