Premature Discontinuation from the Study Treatment Sample Clauses

Premature Discontinuation from the Study Treatment. A subject is deemed to have completed this study if they have completed the entire 156-week treatment period including Visit 16 (the follow-up visit). However, subjects who have prematurely withdrawn from study treatment will be followed up for 156 weeks from the start of treatment. During this period all study drug-related SAEs and all deaths must be reported as per Section 7 of the protocol. Premature discontinuation from the study treatment is when a subject discontinues either voluntarily or is withdrawn by the investigator for reasons such as: an adverse event; if it would be detrimental for the subject to continue; social reasons; lack of efficacy. All subjects who discontinue the study during the treatment period, must have a Follow-up visit two weeks after the withdrawal. In all cases the reason for premature discontinuation must be recorded in the End of Study Record section of the CRF. An adverse event form should be completed if necessary. A subject may voluntarily discontinue participation in this study at any time. The investigator may also, at his or her discretion, discontinue the subject from participating in this study at any time. If the subject has received study drug and is prematurely discontinued from participation in the study for any reason, the investigator must make every effort to perform the following evaluations: collect used/unused study medication and record compliance; check for adverse events, changes in concurrent medication, moderate and severe exacerbations since last visit, perform clinic lung function measurements (FEV1). These data should be recorded at a Follow-up visit, as they comprise an essential evaluation which should be done prior to discharging any subject from the study. In the event that a subject is prematurely discontinued from the study at any time due to an AE (as defined in Section 7.1, Definition of an AE) or SAE (as defined in Section 7.2, Definition of an SAE), the procedures stated in Section 7, (AEs and SAEs) must be followed.
Sample 1
AutoNDA by SimpleDocs

Related to Premature Discontinuation from the Study Treatment

  • Withdrawal of Property from Market or Termination of Discussions Potential Investor acknowledges that the Property has been offered for sale subject to withdrawal of the Property from the market at any time or rejection of any offer because of the terms thereof, or for any other reason whatsoever, without notice, as well as the termination of discussions with any party at any time without notice for any reason whatsoever.

  • Transition from Existing Evaluation System A) The parties may agree that 50% of more of Educators in the district will be evaluated under the new procedures at the outset of this Agreement, and 50% or fewer will be evaluated under the former evaluation procedures for the first year of implementation of the new procedures in this Agreement.

  • Dental Services - Accidental Injury (Emergency Emergency room - When services are due to accidental injury to sound natural teeth. 0% - After deductible The level of coverage is the same as network provider. In a physician’s/dentist’s office - When services are due to accidental injury to sound natural teeth. 0% - After deductible 40% - After deductible Dental Services - Outpatient Services connected to dental care when performed in an outpatient facility * 0% - After deductible 40% - After deductible Covered Benefits - See Covered Healthcare Services for additional benefit limits and details. Network Providers Non-network Providers (*) Preauthorization may be required for this service. Please see Preauthorization in Section 5 for more information. You Pay You Pay Dental Care (Pediatric) - for members under age 19 See Dental Services in Section 3 for benefit limits and details. These services only apply to an enrolled member under the age of 19. Oral evaluations 0% - After deductible 0% - After deductible X-rays 0% - After deductible 0% - After deductible Cleanings (prophylaxis) 0% - After deductible 0% - After deductible Fluoride treatments 0% - After deductible 0% - After deductible Sealants 0% - After deductible 0% - After deductible Space Maintainers 0% - After deductible 0% - After deductible Palliative treatment 50% - After deductible 50% - After deductible Fillings 50% - After deductible 50% - After deductible Simple extractions 50% - After deductible 50% - After deductible Denture repairs and relines/rebasing 50% - After deductible 50% - After deductible Crowns & onlays 50% - After deductible 50% - After deductible Therapeutic Pulpotomies 50% - After deductible 50% - After deductible Root canal therapy 50% - After deductible 50% - After deductible Non-surgical periodontal services 50% - After deductible 50% - After deductible Surgical periodontal services 50% - After deductible 50% - After deductible Periodontal maintenance 50% - After deductible 50% - After deductible Fixed bridges and dentures 50% - After deductible 50% - After deductible Implants 50% - After deductible 50% - After deductible Oral surgery services 50% - After deductible 50% - After deductible General anesthesia or IV sedation - dental office 50% - After deductible 50% - After deductible Biopsies 50% - After deductible 50% - After deductible Occlusal (night) guards 50% - After deductible 50% - After deductible Orthodontic services (braces) - when medically necessary. 50% - After deductible 50% - After deductible Dialysis Services Inpatient/outpatient/in your home 0% - After deductible 40% - After deductible Durable Medical Equipment (DME), Medical Supplies, Diabetic Supplies, Prosthetic Devices, and Enteral Formula or Food, Hair Prosthetics Outpatient durable medical equipment* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient medical supplies* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Outpatient diabetic supplies/equipment purchased at licensed medical supply provider (other than a pharmacy). See the Summary of Pharmacy Benefits for supplies purchased at a pharmacy. 20% - After deductible 40% - After deductible Outpatient prosthesis* - Must be provided by a licensed medical supply provider. 20% - After deductible 40% - After deductible Enteral formula delivered through a feeding tube. Must be sole source of nutrition. 20% - After deductible 40% - After deductible Enteral formula or food taken orally * 20% - After deductible The level of coverage is the same as network provider. Hair prosthesis (wigs) - The benefit limit is $350 per hair prosthesis (wig) when worn for hair loss suffered as a result of cancer treatment. 20% - After deductible The level of coverage is the same as network provider.

  • TREATMENT OF FRINGE BENEFITS The fringe benefits are charged using the rate(s) listed in the Fringe Benefits Section of this Agreement. The fringe benefits included in the rate(s) are listed below. TREATMENT OF PAID ABSENCES Vacation, holiday, sick leave pay and other paid absences are included in salaries and wages and are claimed on grants, contracts and other agreements as part of the normal cost for salaries and wages. Separate claims are not made for the cost of these paid absences.

  • Protection from Unauthorized Use Licensee shall secure that Participating Institutions will use reasonable efforts to restrict access to the Licensed Materials to Authorized Users.

  • Loss Mitigation and Consideration of Alternatives (i) For each Single Family Shared-Loss Loan in default or for which a default is reasonably foreseeable, the Assuming Institution shall undertake reasonable and customary loss mitigation efforts, in accordance with any of the following programs selected by Assuming Institution in its sole discretion, Exhibit 5 (FDIC Mortgage Loan Modification Program), the United States Treasury's Home Affordable Modification Program Guidelines or any other modification program approved by the United States Treasury Department, the Corporation, the Board of Governors of the Federal Reserve System or any other governmental agency (it being understood that the Assuming Institution can select different programs for the various Single Family Shared-Loss Loans) (such program chosen, the “Modification Guidelines”). After selecting the applicable Modification Guideline for each such Single Family Shared-Loss Loan, the Assuming Institution shall document its consideration of foreclosure, loan restructuring under the applicable Modification Guideline chosen, and short-sale (if short-sale is a viable option) alternatives and shall select the alternative the Assuming Institution believes, based on its estimated calculations, will result in the least Loss. If unemployment or underemployment is the primary cause for default or for which a default is reasonably foreseeable, the Assuming Institution may consider the borrower for a temporary forbearance plan which reduces the loan payment to an affordable level for at least six (6) months.

  • How Are Distributions From a Traditional IRA Taxed for Federal Income Tax Purposes Amounts distributed to you are generally includable in your gross income in the taxable year you receive them and are taxable as ordinary income. To the extent, however, that any part of a distribution constitutes a return of your nondeductible contributions, it will not be included in your income. The amount of any distribution excludable from income is the portion that bears the same ratio as your aggregate non-deductible contributions bear to the balance of your Traditional IRA at the end of the year (calculated after adding back distributions during the year). For this purpose, all of your Traditional IRAs are treated as a single Traditional IRA. Furthermore, all distributions from a Traditional IRA during a taxable year are to be treated as one distribution. The aggregate amount of distributions excludable from income for all years cannot exceed the aggregate non-deductible contributions for all calendar years. You must elect the withholding treatment of your distribution, as described in paragraph 22 below. No distribution to you or anyone else from a Traditional IRA can qualify for capital gains treatment under the federal income tax laws. Similarly, you are not entitled to the special five- or ten-year averaging rule for lump-sum distributions that may be available to persons receiving distributions from certain other types of retirement plans. Historically, so-called “excess distributions” to you as well as “excess accumulations” remaining in your account as of your date of death were subject to additional taxes. These additional taxes no longer apply. Any distribution that is properly rolled over will not be includable in your gross income.

  • PRESCRIPTION MEDICATION BENEFITS, LIMITATIONS AND EXCLUSIONS The following items are limited or excluded from your Prescription Medication coverage:

  • Public Benefits This Agreement provides assurances that the Public Benefits identified below will be achieved and developed in accordance with the Applicable Rules and Project Approvals and with the terms of this Agreement and subject to the City’s Reserved Powers. The Project will provide Public Benefits to the City, including without limitation:

  • EVALUATION OF PROJECT BENEFITS The goal of this task is to report the benefits resulting from this project. The Recipient shall:

Time is Money Join Law Insider Premium to draft better contracts faster.