Description of sources Sample Clauses

Description of sources. 5.1 Sources of data that could resolve the key uncertainties identified by the evaluation committee include: • SPR1NT trial [NCT03505099]: SPR1NT is an ongoing Phase III, open- label, single-arm, single-dose, global, multicentre study of onasemnogene abeparvovec in pre-symptomatic infants with genetically diagnosed SMA with two or three copies of the SMN2 gene. After the study follow-up period (18 or 24 months of age), eligible patients have the option to enter the long-term follow-up study (LT- 002). Enrollment is completed and there are two patient cohorts: o Cohort 1: infants with two copies of SMN2 (n=14), followed up to 18 months of age o Cohort 2: infants with three copies of SMN2 (n=15), followed up to 24 months of age
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Description of sources. 5.1 The purpose of the ongoing phase III STAND trial (NCT03814746) is to assess the efficacy and safety of two doses of crizanlizumab (5.0 mg/kg and
Description of sources. 6.1 FIREFISH and SUNFISH are primary sources of data collection; RAINBOWFISH and JEWELFISH are supportive secondary sources. FIREFISH and SUNFISH assess the safety and efficacy of risdiplam; FIREFISH in SMA 1 (infants; 1-7 months) and SUNFISH in SMA 2 and SMA 3 (children and young adults; 2-25 years). SUNFISH is a placebo controlled trial (2:1 risdiplam:placebo). RAINBOWFISH (<6 weeks old) assesses the safety and efficacy of risdiplam in infants with SMA who are not yet showing symptoms. JEWELFISH (children and adults; 6 months - 60 years) assesses the safety and tolerability of risdiplam in people who have previously received SMA treatments (pre-treated patients).
Description of sources. 6.1 RUBY-1 (NCT03981796) is a multicentre, randomised, double blinded, placebo-controlled Phase 3 study. The trial recruited female patients with primary stage III or stage IV endometrial cancer or first recurrent endometrial cancer, with a low potential for cure by radiation therapy or surgery alone or in combination (intention to treat [ITT] N=494) [dMMR/MSI-H n=118]. The trial investigated dostarlimab in combination with carboplatin paclitaxel (N=245) [n=53 dMMR/MSI-H] compared with Placebo in combination with carboplatin paclitaxel (N=249) [n=65 dMMR/MSI-H]. The primary outcomes are PFS by investigator assessment (IA PFS) and Overall survival (OS).

Related to Description of sources

  • Description of Services (a) Services Provided on an Ongoing Basis, If Applicable.

  • Description of Service 2.14.1.1 BellSouth shall make available to <<customer_name>> loop makeup (LMU) data for BellSouth's network facilities. This section addresses LMU as a preordering transaction, distinct from <<customer_name>> ordering any other service(s). Loop Makeup Service Inquiries (LMUSI) for preordering loop makeup are likewise unique from other preordering functions with associated service inquiries (SI) as described in this Agreement.

  • Description of Shares The beneficial interest in the Trust shall be divided into Shares, all without par value. The Trustees shall have the authority from time to time to issue or reissue Shares in one or more Series of Shares (including without limitation the Series specifically established and designated in Section 4.2), as they deem necessary or desirable, to establish and designate such Series, and to fix and determine the relative rights and preferences as between the different Series of Shares as to right of redemption and the price, terms and manner of redemption, special and relative rights as to dividends and other distributions and on liquidation, sinking or purchase fund provisions, conversion rights, and conditions under which the several Series shall have separate voting rights or no voting rights. The Shares of each Series may be issued or reissued from time to time in one or more Classes, as determined by the Board of Trustees pursuant to resolution. Each Class shall be appropriately designated, prior to the issuance of any shares thereof, by some distinguishing letter, number or title. All Shares within a Class shall be alike in every particular. All Shares of each Series shall be of equal rank and have the same powers, preferences and rights, and shall be subject to the same qualifications, limitations and restrictions without distinction between the shares of different Classes thereof, except with respect to such differences among such Classes, as the Board of Trustees shall from time to time determine to be necessary or desirable, including without limitation differences in expenses, in voting rights and in the rate or rates of dividends or distributions. The Board of Trustees may from time to time increase the number of Shares allocated to any Class already created by providing that any unissued Shares of the applicable Series shall constitute part of such Class, or may decrease the number of Shares allocated to any Class already created by providing that any unissued Shares previously assigned to such Class shall no longer constitute part thereof. The Board of Trustees is hereby empowered to classify or reclassify from time to time any unissued Shares of each Series by fixing or altering the terms thereof and by assigning such unissued shares to an existing or newly created Class. Notwithstanding anything to the contrary in this paragraph the Board of Trustees is hereby empowered (i) to redesignate any issued Shares of any Series by assigning a distinguishing letter, number or title to such shares and (ii) to reclassify all or any part of the issued Shares of any Series to make them part of an existing or newly created Class.

  • General Description of Services The A-E will be contacted by COUNTY Project Management staff on an “as-needed” basis as projects arise to provide A-E for professional services. Requirements will be discussed by both Parties and A-E shall prepare a written Scope Statement that will include the specific work to be performed, including the costs and time required to complete the project/task. Orange COUNTY Project Management staff will then review the A-E’s Scope Statement, proceed with negotiation of task costs and when satisfied, issue a Contract Task Order (CTO) against this CONTRACT. The A-E shall serve as lead of a design team that may include other construction design professionals working together to ensure that the original design is carried through to the finished product, with no alterations in materials or design that would lead to safety issues or compromise the quality of the building or building component. Other team members who may be retained by the lead to support a project as a consultant may include but are not limited to landscape architects, lighting designers, data consultants, security consultants, controls engineers, commissioning consultants, traffic engineers, surveyors, estimators, special inspection, etc. The A-E shall be responsible for the preparation of comprehensive building assessments, designs, drawings, specifications, cost estimates, and reports within the scope of the Contract Task Order (CTO). In the preparation of construction drawings and specification, the A-E shall also responsible for:

  • Description of the service 9.1.1 Internet banking service implies an ability for the client to manage and receive remotely the following services from the bank by means of using the special Internet-site of the bank xxxxx://xxx.xxxxxxxxxxxxxxx.xx:

  • Description of the Services 1.1 The scope of the service to be rendered is described more fully in the Annexures and Schedules referred to below: ❑ Annexure A – Scope / Specification ❑ Annexure C – Pricing Schedule 2 DELIVERABLES AND COMPLETION DATE The Deliverables, due for completion by and governed by this Schedule 1. In the event that the Service Provider fails to meet the delivery dates as agreed, the following penalties will be imposed:

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