Schematic Representation of Study Design Sample Clauses

Schematic Representation of Study Design. Approximately 1250 subjects will be randomized *** at up to *** study sites. The randomization schedule will be stratified by *** to ***; at least *** of subjects enrolled into the study will be ***. Subjects will initiate treatment with a dose titration during weeks 1-4 with doses gradually increased at *** intervals, as determined by randomization assignment, until the specified dose is reached and will be treated for 52 weeks (weeks 5-56) at the assigned dose level. Subjects will return to the site at the end of weeks 2 and 4 (Visits 3 and 4) during titration and at 4-week intervals thereafter. A schedule of events is provided in Appendix 1. The primary endpoints are differences between *** and *** groups in mean percent loss of baseline body weight, determined by weight at randomization (baseline) and weight at end of treatment (week 56), and percent of subjects with weight loss of 5% or more at end of treatment (week 56). Percent weight loss will be calculated as ***. Secondary efficacy endpoints are: · The difference in absolute weight loss between randomization (baseline) and end of treatment (week 56) for *** and *** groups. · The difference in percent of subjects who achieve a reduction in total body weight of at least 10% between randomization (baseline) and end of treatment (week 56) for *** and *** groups. · The difference in change in waist circumference (randomization to week 56) for *** and *** groups. Additional efficacy endpoints will include the effect of treatment on obesity-associated cardiovascular risk factors (total cholesterol, triglycerides, LDL-C, HDL-C, fasting glucose, blood pressure), ***, *** of *** and *** and ***, *** and ***. The difference between *** and *** groups in the rate of progression to type 2 diabetes will be calculated. Baseline adjusted Framingham 10-year risk scores will be calculated and compared between groups at weeks 28 and 56. Change in BMI between baseline and week 28 and end of treatment (Visit 17, week 56) will be evaluated. Additionally, body composition will be assessed by *** at ***. These evaluations will be made at ***, and at *** and ***. The change in weight loss (percent, absolute, percent of subjects achieving weight loss of > 5% and > 10% of starting weight), waist circumference and obesity associated risk factors will also be assessed over time. Subgroup analyses, including but not limited to analysis by gender, age and race, may be performed. Safety evaluations will include assessment of ad...
AutoNDA by SimpleDocs

Related to Schematic Representation of Study Design

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Escrow Format Specification Deposit’s Format. Registry objects, such as domains, contacts, name servers, registrars, etc. will be compiled into a file constructed as described in draft-xxxxx-xxxxxxx-registry-data-escrow, see Part A, Section 9, reference 1 of this Specification and draft-xxxxx-xxxxxxx-dnrd-objects-mapping, see Part A, Section 9, reference 2 of this Specification (collectively, the “DNDE Specification”). The DNDE Specification describes some elements as optional; Registry Operator will include those elements in the Deposits if they are available. If not already an RFC, Registry Operator will use the most recent draft version of the DNDE Specification available at the Effective Date. Registry Operator may at its election use newer versions of the DNDE Specification after the Effective Date. Once the DNDE Specification is published as an RFC, Registry Operator will implement that version of the DNDE Specification, no later than one hundred eighty (180) calendar days after. UTF-8 character encoding will be used.

  • Rectification of Safety Hazard Where, because of the existence of a safety hazard, a site has been stopped for a defined period of time and Employees sent off site by agreement between Site Managers and any combination of Union Official/s, Health and Safety Committee, those people who remain on site to do rectification work will be paid at the rate of double time for all such work.

  • Deviation from Grievance Procedure The Employer agrees that, after a grievance has been discussed at Step 2 of the grievance procedure the Employer or his representatives shall not initiate any discussion or negotiations with respect to the grievance, either directly or indirectly with the aggrieved employee without the consent of the xxxxxxx or the Union.

  • Vendor’s Specific Warranties, Terms, and License Agreements Because TIPS serves public entities and non-profits throughout the nation all of which are subject to specific laws and policies of their jurisdiction, as a matter of standard practice, TIPS does not typically accept a Vendor’s specific “Sale Terms” (warranties, license agreements, master agreements, terms and conditions, etc.) on behalf of all TIPS Members. TIPS may permit Vendor to attach those to this Agreement to display to interested customers what terms may apply to their Supplemental Agreement with Vendor (if submitted by Vendor for that purpose). However, unless this term of the Agreement is negotiated and modified to state otherwise, those specific Sale Terms are not accepted by TIPS on behalf of all TIPS Members and each Member may choose whether to accept, negotiate, or reject those specific Sale Terms, which must be reflected in a separate agreement between Vendor and the Member in order to be effective.

  • CERTIFICATION OF NO ASBESTOS CONTAINING MATERIALS OR WORK 8.1 The Contractor shall be responsible for ensuring that no asbestos containing materials or work is included within the scope of the Work. The Contractor shall take whatever measures it deems necessary to insure that all employees, suppliers, fabricators, material men, subcontractors, or their assigns, comply with this requirement. 8.2 The Contractor shall ensure that Texas Department of Health licensed individuals, consultants or companies are used for any required asbestos work including asbestos inspection, asbestos abatement plans/specifications, asbestos abatement, asbestos project management and third-party asbestos monitoring.

  • Recognition of U.S. Special Resolution Regimes (a) In the event a Covered Party becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer of this Agreement (and any interest and obligation in or under, and any property securing, this Agreement) from such Covered Party will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement (and any interest and obligation in or under, and any property securing, this Agreement) were governed by the laws of the United States of America or a State of the United States of America. (b) In the event that a Covered Party or any BHC Affiliate of such Covered Party becomes subject to a proceeding under a U.S. Special Resolution Regime, any Default Right under this Agreement that may be exercised against such Covered Party is permitted to be exercised to no greater extent than such Default Right could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the United States of America or a State of the United States of America.

  • HHS Single Audit Unit will notify Grantee to complete the Single Audit Determination Form If Grantee fails to complete the form within thirty (30) calendar days after receipt of notice, Grantee maybe subject to sanctions and remedies for non-compliance.

  • Certification of Meeting or Exceeding Tobacco-Free Workplace Policy Minimum Standards A. Grantee certifies that it has adopted and enforces a Tobacco-Free Workplace Policy that meets or exceeds all of the following minimum standards of: i. Prohibiting the use of all forms of tobacco products, including but not limited to cigarettes, cigars, pipes, water pipes (hookah), bidis, kreteks, electronic cigarettes, smokeless tobacco, snuff and chewing tobacco; ii. Designating the property to which this Policy applies as a "designated area,” which must at least comprise all buildings and structures where activities funded under this Grant Agreement are taking place, as well as Grantee owned, leased, or controlled sidewalks, parking lots, walkways, and attached parking structures immediately adjacent to this designated area; iii. Applying to all employees and visitors in this designated area; and iv. Providing for or referring its employees to tobacco use cessation services. B. If Grantee cannot meet these minimum standards, it must obtain a waiver from the System Agency.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!