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 ▇▇▇▇) 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 ▇▇▇▇) hernia repair using LiquiBand FIX8® or control device. The incidence of hernia recurrence in patients following laparoscopic (TEP and ▇▇▇▇) 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 ▇▇▇▇ 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 (▇▇▇▇ repairs only) at time of ...
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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 Chapter shall apply, in accordance with the Parties’ respective international obligations and domestic customs law, to customs procedures applied to goods traded between the Parties and to the movement of means of transport between the Parties. 2. The objectives of this Chapter are to: (a) simplify and harmonise customs procedures of the Parties; (b) ensure predictability, consistency and transparency in the application of customs laws and administrative procedures of the Parties; (c) ensure the efficient and expeditious clearance of goods and means of transport; (d) facilitate trade between the Parties; and (e) promote cooperation between the customs administrations, within the scope of this Chapter.

  • Project Objectives 1.1 (Type the Project objectives)

  • Program Objectives Implement a rigorous constructability program following The University of Texas System, Office of Capital Projects 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 For the purposes of this Access Agreement, the University of Bristol will assess progress in widening participation against a combination of progress measures which, between them, are designed to assess: • The specific impact of a number of key outreach initiatives. • Year on year progress in diversifying our applicant and student population. • Year on year progress in improving conversion of under-represented applicants. Bearing in mind the range of outreach activities which we plan to offer, we intend to measure year on year progress in attracting a wider pool of applicants by focusing particularly on each of the following categories (although additional measures included in our 2012 Agreement have also been retained for continuity of monitoring): • Applicants from low performing schools • Applicants from socio-economic groups 4-7 • Local applicants Progress measures for each of these are provided at Appendix Four. In each case, we have included new measures, to assess improvements in application to intake conversion. As far as possible, measures have been calculated taking account of the expected impact of a number of specific outreach initiatives (the Access to Bristol scheme, summer school programme and personal adviser scheme), each of which also has more detailed performance targets associated with them (also detailed at Appendix Four). Measurement of the University’s intake profile will be focused on the low school performance category, reflecting the role which this plays in our contextual approach to admissions. Measures relating to mature student intake have been included for continuity. The recent decision to grow our undergraduate numbers substantially means that continuing to measure progress in diversifying intake by looking at under-represented groups as a percentage of total intake is no longer meaningful. For each intake-related measure, we have therefore added the number of students which the original percentages might have been expected to deliver. Monitoring against these numbers will give a more accurate picture of progress. All progress measures have been informed by more detailed analysis of progress against the institutional milestones detailed in Appendix Two and will be re-calculated annually to reflect assessment of our progress to date. In addition, it should be noted that we intend to carry out further research, for example, to better understand the impact of educational standards in the Bristol area on our ability to progress at the specified rates; we may need to adjust the progress measures contained in this agreement for future years to reflect the findings.