Potential Benefits and Risks Sample Clauses

Potential Benefits and Risks. Protocol 217-PPD-201 is the first clinical study of SAGE-217 evaluating the efficacy, safety, and pharmacokinetics in subjects with PPD. Thus, the potential benefits in this population are unknown, although the risks are likely to be similar to those noted in the Investigator’s Brochure. Known risks of severe PPD include maternal suicide, infanticide, decreased maternal bonding with the infant, resulting in poor attachment (Xxxxxxx 2005; XxXxxxx 2006; Austin 2007; Xxxxxxx-Xxxxx 2014). It has also been demonstrated that effects of PPD extend to the paternal mood and, as a result, negatively impact the functioning of the entire family (Xxxxxxx 2010). In order to mitigate risks associated with this study, dose adjustments based on tolerability are allowed in the protocol. In the 217-CLP-103 study, SAGE-217 was found to be generally well-tolerated with no serious adverse events (AEs) reported during the treatment and follow-up periods. The most frequent AE observed was sedation that was mild, transient, and occurred within 1 to 4 hours and generally dissipated by 8 hours. In conclusion, the known safety profile, coupled with exclusion of high-risk patients with attempted suicide associated with the current episode of depression, are expected to place this protocol at a favorable benefit to risk ratio.
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Potential Benefits and Risks. The potential benefits and risks of research participation listed below are examples that are recommended for inclusion in the informed consent materials of data contributors.

Related to Potential Benefits and Risks

  • General Benefits During the Term of Employment, the Executive shall be entitled to participate in such employee pension and welfare benefit plans and programs of the Company as are made available to the Company's senior-level executives or to its employees generally, as such plans or programs may be in effect from time to time, including, without limitation, health, medical, dental, long-term disability, travel accident and life insurance plans.

  • Medical Benefits The Company shall reimburse the Employee for the cost of the Employee's group health, vision and dental plan coverage in effect until the end of the Termination Period. The Employee may use this payment, as well as any other payment made under this Section 6, for such continuation coverage or for any other purpose. To the extent the Employee pays the cost of such coverage, and the cost of such coverage is not deductible as a medical expense by the Employee, the Company shall "gross-up" the amount of such reimbursement for all taxes payable by the Employee on the amount of such reimbursement and the amount of such gross-up.

  • Complaints and Compensation If you have a complaint of any kind, please be sure to let us know. We will do our utmost to resolve the issue. You can put your complaint in writing to us at: Complaint Resolution Team, Equiniti Financial Services Limited, Aspect House, Xxxxxxx Road, Lancing, West Sussex, BN99 6DA United Kingdom or email us at: xxxxxxxx@xxxxxxxx.xxx or call us using the contact details in Section 1. If we cannot resolve the issue between us, you may – so long as you are eligible – ask the independent Financial Ombudsman Service to review your complaint. A leaflet with more details about our complaints procedure is available – you are welcome to ask us to supply you with a copy at any time. We are a member of the Financial Services Compensation Scheme, set up under the Financial Services and Markets Act 2000. If we cannot meet our obligations, you may be entitled to compensation from the Scheme. This will depend on the type of agreement you have with us and the circumstances of the claim. For example, the Scheme covers corporate sponsored nominees, individual savings accounts and share dealing. Most types of claims for FCA regulated business are covered for 100% of the first £50,000 per person. This limit is applicable to all assets with Equiniti FS. For more details about the Financial Services Compensation Scheme, you can call their helpline: 0800 678 1100 or +00 000 000 0000 or go to their website at: xxx.xxxx.xxx.xx or write to them at: Financial Services Compensation Scheme 10th Floor, Beaufort House, 00 Xx Xxxxxxx Xxxxxx, Xxxxxx XX0X 0XX Xxxxxx Xxxxxxx Alternative Formats

  • Covered Benefits and Services The Contractor shall provide to its Hoosier Healthwise members, at a minimum, all benefits and services deemed “medically reasonable and necessary” and covered by the IHCP, and included in the Indiana Administrative Code and under the Contract with the State. A covered service is considered medically necessary if it meets the definition as set forth in 405 IAC 5-2-17. The Contractor shall deliver covered services sufficient in amount, duration or scope to reasonably expect that provision of such services would achieve the purpose of the furnished services. Costs for these services are the basis of the Contractor’s capitation rate and are, therefore, the responsibility of the Contractor. Coverage may not be arbitrarily denied or reduced and is subject to certain limitations in accordance with CFR 438.210(a)(4), which specifies when Contractors may place appropriate limits on services:  On the basis of criteria applied under the State plan, such as medical necessity; or  For the purpose of utilization control, provided the services furnished are sufficient in amount, duration or scope to reasonably be expected to achieve the purpose for which the services are furnished.

  • Workplace Safety Insurance Benefits (WSIB) Top Up Benefits If the employee is in a class of employees that, on August 31, 2012, was entitled to use unused sick leave credits for the purpose of topping up benefits received under the Workplace Safety and Insurance Act, 1997;

  • Job Benefits and Protection The District shall insure the following provisions:

  • IN EMPLOYMENT, SERVICES, BENEFITS AND FACILITIES Contractor and any subcontractors shall comply with all applicable federal, state, and local Anti-discrimination laws, regulations, and ordinances and shall not unlawfully discriminate, deny family care leave, harass, or allow harassment against any employee, applicant for employment, employee or agent of County, or recipient of services contemplated to be provided or provided under this Agreement, because of race, ancestry, marital status, color, religious creed, political belief, national origin, ethnic group identification, sex, sexual orientation, age (over 40), medical condition (including HIV and AIDS), or physical or mental disability. Contractor shall ensure that the evaluation and treatment of its employees and applicants for employment, the treatment of County employees and agents, and recipients of services are free from such discrimination and harassment. Contractor represents that it is in compliance with and agrees that it will continue to comply with the Americans with Disabilities Act of 1990 (42 U.S.C. § 12101 et seq.), the Fair Employment and Housing Act (Government Code §§ 12900 et seq.), and ensure a workplace free of sexual harassment pursuant to Government Code 12950 and regulations and guidelines issued pursuant thereto. Contractor agrees to compile data, maintain records and submit reports to permit effective enforcement of all applicable antidiscrimination laws and this provision. Contractor shall include this nondiscrimination provision in all subcontracts related to this Agreement and when applicable give notice of these obligations to labor organizations with which they have Agreements.

  • Coordination of Benefits and Subrogation IPA and HMO shall establish and implement a system for coordination of benefits and subrogation, in accordance with those rules established under the HMO's policies and procedures and applicable federal and state laws. If known to IPA, IPA shall identify and inform HMO of Members for whom coordination of benefits and subrogation opportunities exist. HMO hereby authorizes IPA to seek payment, on a fee-for service basis or otherwise, from any insurance carrier, organization, or government agency which is primarily responsible for the payment or provision of medical services provided by IPA under this Agreement which can be recovered by reason of coordination of benefits, motor vehicle injury, worker's compensation, temporary disability, occupational disease, or similar exclusionary or limiting provisions, to the extent authorized by the applicable and not otherwise prohibited by law.

  • ’ Compensation and Employer’s Liability The policy is required only if Contractor has employees. The policy must include workers’ compensation to meet minimum requirements of the California Labor Code, and it must provide coverage for employer’s liability bodily injury at minimum limits of $1,000,000 per accident or disease.

  • Salaries and Benefits (i) Seller shall be responsible for (A) the payment of all wages and other remuneration due to Active Employees with respect to their services as employees of Seller through the close of business on the Closing Date, including pro rata bonus payments and all vacation pay earned prior to the Closing Date; and (B) the payment of any termination or severance payments and the provision of health plan continuation coverage in accordance with the requirements of COBRA and Sections 601 through 608 of ERISA.

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