Sample Size and Power Considerations Sample Clauses

Sample Size and Power Considerations. This study is designed to estimate and assess the significance of the difference between a 200- mcg dose of IPP-201101 and placebo in the proportion of SRI responders at week 52. With 100 evaluable patients per group (200 in total), this study will have 90% or greater power to detect a 25% or greater difference in the proportion of SRI responders between the IPP-201101 group and the placebo group or to detect a 20% difference with an 80%power. This projection using the Xxxxxxx Xxx-square test (2-sided, alpha=0.05) is based on an anticipated placebo effect at week 52 of 40% to 45%. This range covers the placebo effect reported in the literature (Navarra et al 2009, xxx Xxxxxxxxxxx et al 2010, Xxxxxxx et al 2009) and in a Phase 2b, multicenter, randomized, double-blind, placebo-controlled dose-ranging study of IPP-201101 (study IP-004). The difference between placebo and active which is used in the sample size calculation is 25% based on the results of the Phase IIb study (IP-004) with the same formulation (Xxxxxx et al. ACR 2012)
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Related to Sample Size and Power Considerations

  • Existence and Power The Seller is a limited liability company validly existing and in good standing under the laws of the State of Delaware and has, in all material respects, all power and authority required to carry on its business as it is now conducted. The Seller has obtained all necessary licenses and approvals in each jurisdiction where the failure to do so would materially and adversely affect the ability of the Seller to perform its obligations under the Transaction Documents or affect the enforceability or collectibility of the Receivables or any other part of the Transferred Assets.

  • Other Considerations A. Changes to an Approved Scope of Work: The Recipient shall notify FEMA and shall require a sub-recipient to notify it immediately when a sub-recipient proposes changes to an approved scope of work for an Undertaking.

  • General Considerations a. All reports, drawings, designs, specifications, notebooks, computations, details, and calculation documents prepared by Vendor and presented to the Board pursuant to this Agreement are and remain the property of the Board as instruments of service.

  • Special Considerations Special considerations in determining allowability of compensation will be given to any change in a non-Federal entity's compensation policy resulting in a substantial increase in its employees' level of compensation (particularly when the change was concurrent with an increase in the ratio of Federal awards to other activities) or any change in the treatment of allowability of specific types of compensation due to changes in Federal policy.

  • Purposes and Powers The purpose of the Trust is to engage in the following activities:

  • Organization and Power The Purchaser is duly organized, validly existing, and in good standing under the laws of the jurisdiction of its formation and has all requisite power and authority to carry on its business as presently conducted and as proposed to be conducted.

  • Additional Considerations For each mediation or arbitration:

  • Treatment of Passthru Payments and Gross Proceeds The Parties are committed to work together, along with Partner Jurisdictions, to develop a practical and effective alternative approach to achieve the policy objectives of foreign passthru payment and gross proceeds withholding that minimizes burden.

  • Corporate Existence and Power It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.

  • RISK CONSIDERATION There are no significant risks associated with the recommendations contained within this report. This application may be considered under existing MPS policies. Community Council has the discretion to make decisions that are consistent with the MPS, and such decisions may be appealed to the N.S. Utility and Review Board. Information concerning risks and other implications of adopting the proposed development agreement are contained within the Discussion section of this report. ENVIRONMENTAL IMPLICATIONS No environmental implications are identified.

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