Participant Inclusion Criteria Sample Clauses

Participant Inclusion Criteria. Participants must meet all of the following criteria to qualify for participation in this study: 1. Participant has signed an ICF prior to any study-specific procedures being performed. 2. Participant is an ambulatory female between 18 and 45 years of age, inclusive. 3. Participant is in good physical health and has no clinically significant findings, as determined by the investigator, on physical examination, . 4. Participant agrees to adhere to the study requirements, including not participating in night shift work. 5. Participant has ceased lactating or agrees not to provide breastmilk to her infant(s) from just prior to receiving IP on Day 1 until 7 days after the last dose of IP. 6. Participant must have a negative pregnancy test at screening and Day 1 prior to the start of IP administration. 7. Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, and meets criteria for major depressive episode per DSM-5, diagnosed by SCID-5-CT. 8. Participant has a HAM-D total score of ≥26 at screening and Day 1 (prior to randomization). 9. Participant is ≤12 months postpartum at screening and Day 1. 10. Participants taking antidepressants must have been taking these medications at the same dose for at least 30 days prior to Day 1. Participants who have stopped taking antidepressants within 30 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1, and will be stratified into the “no antidepressant group”. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 30 days prior to Day 1. 11. Participant is willing to delay the start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 45 visit. 12. Participant agrees to use at least one method of highly effective contraception as listed in Section 9.2.4 during participation in the study and for 30 days following the last dose of IP, unless she is surgically sterile (bilateral oophorectomy, hysterectomy, and/or bilateral salpingectomy), or does not engage in sexual relations which carry a risk of pregnancy (does not include abstinence). 13. Participant agrees to refrain from drugs of abuse and alcohol for the duration of the study.
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Related to Participant Inclusion Criteria

  • Selection Criteria Each Contract is secured by a new or used Motorcycle. No Contract has a Contract Rate less than 1.00%. Each Contract amortizes the amount financed over an original term no greater than 84 months (excluding periods of deferral of first payment). Each Contract has a Principal Balance of at least $500.00 as of the Cutoff Date.

  • Evaluation Criteria 5.2.1. The responses will be evaluated based on the following: (edit evaluation criteria below as appropriate for your project)

  • Award Criteria 40.1 The Procuring Entity shall award the Contract to the successful tenderer whose tender has been determined to be the Lowest Evaluated Tender in accordance with procedures in Section 3: Evaluation and Qualification Criteria.

  • Criteria (1) Annual Evaluation Criteria. All performance evaluations shall be based upon assigned duties, and shall carefully consider the nature of the assignment in terms, where applicable, of: a. Teaching effectiveness, including effectiveness in presenting knowledge, information, and ideas by means or methods such as lecture, discussion, assignment and recitation, demonstration, laboratory exercise, practical experience, supervision of interns, theses, professional projects and/or dissertations, and direct consultation with students. The evaluation shall include consideration of effectiveness in imparting knowledge and skills, and effectiveness in stimulating students' critical thinking and/or creative abilities, the development or revision of curriculum and course structure, and adherence to accepted standards of professional behavior in meeting responsibilities to students. The evaluator may take into account class notes, syllabi, student exams and assignments, and any other materials relevant to the employee's teaching assignment. The teaching evaluation must take into account any relevant materials submitted by the employee, including the results of peer evaluations of teaching, and may not be based solely on student evaluations when this additional information has been made available to the evaluator. b. Contribution to the discovery of new knowledge, development of new educational techniques, and other forms of creative activity. Evidence of research and other creative activity shall include, but not be limited to, published books; articles and papers in professional journals; musical compositions, paintings, sculpture; works of performing art; papers presented at meetings of professional societies; funded grant activities; and research and creative accomplishments that have not yet resulted in publication, display, or performance. The evaluation shall include consideration of the employee's productivity, including the quality and quantity of the employee's research and other creative programs and contributions during the year, as well as recognition by the academic or professional community of what has been done. c. Public service that extends professional or discipline-related contributions to the community, the State, public schools, and/or the national and international community. This public service includes contributions to scholarly and professional organizations, governmental boards, agencies, and commissions that are beneficial to such groups and individuals. d. Participation in the governance processes of the University through significant service on committees, councils, and senates, beyond that associated with the expected responsibility to participate in the governance of the University through participation in regular departmental or college meetings. e. Other assigned University duties, such as attending University events, advising, counseling, and academic administration, or as described in a Position Description, if any, of the position held by the employee. Other assigned duties may include entrepreneurial activities that contribute to the further development of the University with an end result of creating a new venture. Evidence of entrepreneurial contributions shall include, but not be limited to, creation of self- supporting centers or institutes, development of multi- disciplinary research partnerships, and applications of research to implementations in society. To provide guidelines for the establishment, maintenance and use of employee evaluation files within the employee’s respective academic unit.

  • Performance Testing 7.2.1 The Design-Builder shall direct and supervise the tests and, if necessary, the retests of the Plant using Design-Builder’s supervisory personnel and the Air Emissions Tester shall conduct the air emissions test, in each case, in accordance with the testing procedures set forth in Exhibit A (the “Performance Tests”), to demonstrate, at a minimum, compliance with the Performance Guarantee Criteria. Owner is responsible for obtaining Air Emissions Tester and for ensuring Air Emissions Tester’s timely performance. Design-Builder shall cooperate with the Air Emissions Tester to facilitate performance of all air emissions tests. Design-Builder shall not be held responsible for the actions of Owner’s employees and third parties involved in the Performance Testing, including but not limited to Air Emissions Tester. 7.2.2 No later than thirty (30) Days prior to the earlier of the Scheduled Substantial Completion Date or Substantial Completion, Design-Builder shall provide to Owner for review a detailed testing plan for the Performance Tests (other than for air emissions). Owner and Design-Builder shall agree upon a testing plan that shall be consistent with the Performance Test Protocol contained in Exhibit A hereto. After such agreement has been reached, Design-Builder shall notify the Owner five (5) business days prior to the date Design-Builder intends to commence the Performance Tests and shall notify the Owner upon commencement of the Performance Tests. Owner and Independent Engineer each have the right to witness all testing, including the Performance Tests and any equipment testing, whether at the Site or at the Subcontractor’s or equipment supplier’s premises during the course of this Agreement. Notwithstanding the foregoing sentence, Owner shall bear the costs of providing a witness to any such testing and all such witnesses shall comply at all times with Design-Builder’s, Subcontractor’s or equipment supplier’s safety and security procedures and other reasonable requirements, and otherwise conduct themselves in a manner that does not interfere with Design-Builder’s, Subcontractor’s or equipment supplier’s activities or operations. 7.2.3 Design-Builder shall provide to Owner a Performance Test report (excluding results from air emissions testing), including all applicable test data, calculations and certificates indicating the results of the Performance Tests and, within five (5) business days of Owner’s receipt of such results, Owner, Independent Engineer and Design-Builder will jointly inspect such Work and review the results of the Performance Tests to verify that the Performance Guarantee Criteria have been met. If Owner or Independent Engineer reasonably determines that the Performance Guarantee Criteria have not been met, Owner shall notify Design-Builder the reasons why Owner determined that the Performance Guarantee Criteria have not been met and Design-Builder shall promptly take such action or perform such additional work as will achieve the Performance Guarantee Criteria and shall issue to the Owner another notice in accordance with Section 7.2.2; provided however that if the notice relates to a retest, the notice may be provided no less than two (2) business days prior to the Performance Tests. Such procedure shall be repeated as necessary until Owner and Independent Engineer verifies that the Performance Guarantee Criteria have been met. 7.2.4 If Owner, for whatever reason, prevents Design-Builder from demonstrating the Performance Guarantee Criteria within thirty (30) Days of Design-Builder’s notice that the Plant is ready for Performance Testing, then Design-Builder shall be excused from demonstrating compliance with the Performance Guarantee Criteria during such period of time that Design-Builder is prevented from demonstrating compliance with the Performance Guarantee Criteria; provided however that Design-Builder will be deemed to have fulfilled all of its obligations to demonstrate that the Plant meets the Performance Guarantee Criteria should such period of time during which Design-Builder is prevented from demonstrating the Performance Criteria exceed thirty (30) Days or extend beyond the Final Completion Date.

  • 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.

  • Claims Review Population A description of the Population subject to the Claims Review.

  • General Criteria (a) If general criteria are required as part of the Application, only one (1) set shall be completed. General criteria measure the quality of the Land Manager’s overall OHV program. The Applicants shall answer these questions with respect to the entirety of the OHV operation, including all trails and areas available for OHV Recreation, not just specific Projects or Project Areas. (b) General criteria include, but are not limited to, the following: (1) OHV Opportunity and services provided, (2) Agency contribution to the overall cost of managing and delivering the OHV Opportunity, (3) Management of natural and Cultural Resources, (4) Effective education of rules/regulations, and (5) Past performance in completing and administering Xxxxx funded Projects. (c) Non-land manager Applicants required to complete the general criteria shall cooperate with the Land Manager(s) to obtain the information necessary to complete the general criteria section of the Application. Note: Authority cited: Sections 5001.5 and 5003, Public Resources Code. Reference: Sections 5024.1, 5090.32 and 5090.50, Public Resources Code.

  • Long Term Cost Evaluation Criterion 4. READ CAREFULLY and see in the RFP document under "Proposal Scoring and Evaluation". Points will be assigned to this criterion based on your answer to this Attribute. Points are awarded if you agree not increase your catalog prices (as defined herein) more than X% annually over the previous year for the life of the contract, unless an exigent circumstance exists in the marketplace and the excess price increase which exceeds X% annually is supported by documentation provided by you and your suppliers and shared with TIPS, if requested. If you agree NOT to increase prices more than 5%, except when justified by supporting documentation, you are awarded 10 points; if 6% to 14%, except when justified by supporting documentation, you receive 1 to 9 points incrementally. Price increases 14% or greater, except when justified by supporting documentation, receive 0 points. increases will be 5% or less annually per question Required Confidentiality Claim Form This completed form is required by TIPS. By submitting a response to this solicitation you agree to download from the “Attachments” section, complete according to the instructions on the form, then uploading the completed form, with any confidential attachments, if applicable, to the “Response Attachments” section titled “Confidentiality Form” in order to provide to TIPS the completed form titled, “CONFIDENTIALITY CLAIM FORM”. By completing this process, you provide us with the information we require to comply with the open record laws of the State of Texas as they may apply to your proposal submission. If you do not provide the form with your proposal, an award will not be made if your proposal is qualified for an award, until TIPS has an accurate, completed form from you. Read the form carefully before completing and if you have any questions, email Xxxx Xxxxxx at TIPS at xxxx.xxxxxx@xxxx-xxx.xxx If the vendor is awarded a contract with TIPS under this solicitation, the vendor agrees to make any Choice of Law clauses in any contract or agreement entered into between the awarded vendor and with a TIPS member entity to read as follows: "Choice of law shall be the laws of the state where the customer resides" or words to that effect.

  • Claims Review Methodology ‌‌ a. C laims Review Population. A description of the Population subject‌‌ to the Quarterly Claims Review.

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