Potential Risks and Benefits Sample Clauses

Potential Risks and Benefits. The apparent risks of SAGE-217 are based on both nonclinical and clinical data in completed and ongoing studies and the known pharmacology of the drug. SAGE-217 has been generally well-tolerated in clinical studies. Somnolence, sedation, and dizziness were identified as adverse drug reactions. Most AEs were reported as mild or moderate in intensity and reversible. The proposed 50-mg or 40-mg doses have not been studied in participants with PPD, but the benefit-risk profile is expected to be acceptable (see Section 5.3). Refer to the Investigator’s Brochure for a detailed description of the chemistry, pharmacology, efficacy, and safety of SAGE-217. SAGE-217 may present a treatment option for PPD that has more rapid onset of action (days instead of weeks) when compared to current standard of care. Based on nonclinical findings, embryo-fetal toxicity and withdrawal effects are considered important potential risks for SAGE-217. Risk mitigation measures in this study include monitoring for adverse effects, monitoring for potential withdrawal effects, requiring highly effective contraceptive measures for study participants, and inclusion of dose adjustment criteria. Finally, due to the sedation/somnolence observed, SAGE-217 is administered in the evening in this study. Given the outcome of the completed studies of SAGE-217 in adults with MDD and PPD, the current significant unmet need in the treatment of depression, and a favorable benefit-risk profile, further investigation of SAGE-217 in adults with PPD is justified.
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Potential Risks and Benefits. There is no more than minimal risk to the participants. Some risks were associated with the participants’ fears that their responses would be revealed to their supervisors, i.e. DHs, VPs, the principal, the supervising departments or the head office. This could have lead to a situation when the participants would feel reluctant to provide honest responses and in-depth insights. To avoid such an unwillingness, I assured the interviewees about the strictly confidential character of conversations and about how the data would be treated, and in which form it might appear in public. More broadly, benefits of the proposed research for the participants and the research site were related to making a contribution to the development of new knowledge in the field of SDP in Kazakhstani context. Locally, it is advantageous for the research participants to obtain the research findings and conclusions for improving their current practices. The participants were informed that there would be no financial benefits for them.
Sample 1
Potential Risks and Benefits. 2.3.1 POTENTIAL RISKS Potential risks are limited to the minor risks associated with phlebotomy and the small risk of subject confidentiality being compromised. As this study does not involve any intervention, we do not expect to add any additional risks other than the ones inherent to standard of care, to participants.
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Potential Risks and Benefits 
Sample 1

Related to Potential Risks and Benefits

  • 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.

  • Insurance and Benefits Company shall allow Executive to participate in each employee benefit plan and to receive each executive benefit that Company provides for senior executives at the level of Executive's position.

  • Risks and Benefits of Therapy Psychotherapy is a process in which Therapist and Patient discuss a myriad of issues, events, experiences and memories for the purpose of creating positive change so Patient can experience his/her life more fully. It provides an opportunity to better, and more deeply understand oneself, as well as, any problems or difficulties Patient may be experiencing. Psychotherapy is a joint effort between Patient and Therapist. Progress and success may vary depending upon the particular problems or issues being addressed, as well as many other factors. Participating in therapy may result in a number of benefits to Patient, including, but not limited to, reduced stress and anxiety, a decrease in negative thoughts and self-sabotaging behaviors, improved interpersonal relationships, increased comfort in social, work, and family settings, increased capacity for intimacy, and increased self-confidence. Such benefits may also require substantial effort on the part of Patient, including an active participation in the therapeutic process, honesty, and a willingness to change feelings, thoughts and behaviors. There is no guarantee that therapy will yield any or all of the benefits listed above. Participating in therapy may also involve some discomfort, including remembering and discussing unpleasant events, feelings and experiences. The process may evoke strong feelings of sadness, anger, fear, etc. There may be times in which Therapist will challenge Patient’s perceptions and assumptions, and offer different perspectives. The issues presented by Patient may result in unintended outcomes, including changes in personal relationships. Patient should be aware that any decision on the status of his/her personal relationships is the responsibility of Patient. During the therapeutic process, many patients find that they feel worse before they feel better. This is generally a normal course of events. Personal growth and change may be easy and swift at times, but may also be slow and frustrating. Patient should address any concerns he/she has regarding his/her progress in therapy with Therapist. Professional Consultation Professional consultation is an important component of a healthy psychotherapy practice. As such, Therapist regularly participates in clinical, ethical, and legal consultation with appropriate professionals. During such consultations, Therapist will not reveal any personally identifying information regarding Patient.

  • Rights and Benefits In all policies of D&O Insurance, the Indemnitee shall be named as an insured in such a manner as to provide the Indemnitee the same rights and benefits as are accorded to the most favorably insured of the Company’s directors, if the Indemnitee is a director; or of the Company’s officers, if the Indemnitee is not a director of the Company but is an officer; or of the Company’s key employees, if the Indemnitee is not a director or officer but is a key employee.

  • PRESENT CONDITIONS AND BENEFITS All rights, benefits and working conditions which employees now enjoy, receive or possess as employees of the Employer shall continue to be enjoyed and possessed insofar as they are consistent with this Agreement but may be modified by mutual agreement between the Employer and the Union.

  • Wages and Benefits Wages, performance sharing opportunities and benefits as identified in this Section 2 are considered to be ongoing obligations and will terminate at the extended expiration of local agreements, rather than at the expiration of this Agreement.

  • PAY, HOURS AND BENEFITS III.A. WAGES

  • Training Benefits In the event that the Employer should introduce new methods or machines which require new or greater skills than are possessed by employees under the present method of operation, such employees shall, at the expense of the Employer, be given a reasonable period of time, in the opinion of the Employer, during which they may perfect or acquire the skills necessitated by the new method of operation. There shall be no change in wage or salary rates during the training period of any such employee.

  • Waiting Period and Benefits (A) Employees Disabled Prior to April 1, 1998 * (* See Explanatory Note in Preamble to this Addendum.) In the event an employee, while enrolled in this Plan, becomes totally disabled prior to April 1, 1998 as a result of an accident or a sickness, then, after the employee has been totally disabled for six (6) months the employee shall receive a benefit equal to two-thirds (2/3) of monthly earnings.

  • Effective Date of Wages and Benefits All non-compensatory provisions, wages and benefits shall be effective from Date of Ratification unless otherwise specified in this Collective Agreement.

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