Discontinuation of Study Drug Sample Clauses

Discontinuation of Study Drug. Subjects who discontinue study drug post-randomization will complete the Week 12/Early Withdrawal assessments specified in the Schedule of Assessments (Section 1.3). Reasons for discontinuation from double-blind study drug treatment and the study include the following: • Adverse event (AE) • Lack of efficacy • Noncompliance • Withdrawal of consent • Lost to follow-up • Physician decision • Protocol deviation • Pregnancy • Death • Other Discontinuation of study drug for abnormal liver function should be considered by the Investigator when a subject meets all of the conditions outlined in Section 8.4.7.2 for Hy’s law or if the Investigator believes that it is in the best interest of the subject (reason for discontinuation will be AE). Reporting and follow-up requirements for pregnancy are provided in Section 8.4.5 and Section 10.6.2. For subjects who are not randomized into the 12-week double-blind treatment period and, therefore, are either screen failures or run-in failures, the End of Study eCRF should be completed (refer to eCRF completion guidelines for additional information).
Sample 1
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Discontinuation of Study Drug. ‌ Indications for study drug discontinuation include symptoms of hypocalcemia confirmed on blood assay and development of an acute fall in urine output confirmed by a rise in creatinine. Additional indications for discontinuation include the development of a study drug related SAE during infusion or any other study drug related adverse event that the investigator believes warrants discontinuation.
Sample 1
Discontinuation of Study Drug. ‌ If a subject discontinues study drug early for any reason they should be encouraged to return for an Early Discontinuation of Study Drug Visit (Refer to section 10.6). Subjects will not be withdrawn from the study and will be encouraged to complete all remaining visits and procedures. If a subject discontinues study drug due to a related AE, the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized.
Sample 1

Related to Discontinuation of Study Drug

  • Discontinuation of Service If there are unavoidable reasons (including but not limited to technical reasons), SORACOM may discontinue provision of the SORACOM Air Global Service in whole or part.

  • Discontinuation Either party may discontinue the job/time sharing arrangement with ninety

  • Evaluation of Students Acknowledging the District’s adopted grading system, the teacher shall maintain the right and responsibility to determine grades and other evaluation of a student. No grade or evaluation shall be changed except by the teacher with the approval of the building administrator.

  • Continuation of Health Benefits An eligible employee who is on an approved FML Leave shall be entitled to continue participation in health plan coverage (medical, dental, and optical) as follows:

  • Continuation of Plan Subject to the continuing approval of the Commissioner of Internal Revenue, to the extent available, and of other cognizant governmental authorities, as more particularly hereinafter specified, and to the provisions of 17.5, a Retirement Plan (hereinafter called the Plan) in the form now in effect as to the employees within the units to which this Agreement relates shall continue to be effective while this Agreement is in effect as to such employees in accordance with and subject to the terms, conditions, and limitations of the Plan.

  • Transportation of Students Employees will not be required to transport students.

  • Continuation of Work Pending the resolution of any dispute or claim pursuant to this Article 11, the Parties agree that performance of all obligations will be pursued diligently.

  • Continuation of Benefits Following the termination of Executive’s employment hereunder, the Executive shall have the right to continue in the Company’s group health insurance plan or other Company benefit program as may be required by COBRA or any other federal or state law or regulation.

  • Continuation of Agreement This Agreement shall become effective for each Fund as of the date first set forth above and shall continue in effect for each Fund until August 1, 2010, unless sooner terminated as hereinafter provided, and shall continue in effect from year to year thereafter for each Fund only as long as such continuance is specifically approved at least annually (i) by either the Board of Directors or by the vote of a majority of the outstanding voting securities of such Fund, and (ii) by the vote of a majority of the Directors, who are not parties to the Agreement or interested persons of any such party, cast in person at a meeting called for the purpose of voting on such approval. The annual approvals provided for herein shall be effective to continue this Agreement from year to year if given within a period beginning not more than 90 days prior to August 1st of each applicable year, notwithstanding the fact that more than 365 days may have elapsed since the date on which such approval was last given.

  • Separation of Components The SOFTWARE PRODUCT is licensed as a single product. Its component parts may not be separated for use on more than one computer.

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