Study Design and Randomization Sample Clauses

Study Design and Randomization. This is a Phase 3 randomized, double-blind, parallel-group, placebo-controlled study. Treatment assignment will be stratified for the following 3 baseline characteristics (as described in section 3.3): by region, SLEDAI-2K screening total score (6 to 9 or ≥10), and racial-ethnic group classification (black/Hispanic or others). Within each stratum, eligible patients will be randomly assigned with a 1:1 ratio to receive either 200 mcg of IPP-201101 or placebo sc every 4 weeks for 48 weeks. Study investigators, patients, and ImmuPharma study staff will be blinded to the treatment assignments during the study.
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Related to Study Design and Randomization

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Screening 3.13.1 Refuse containers located outside the building shall be fully screened from adjacent properties and from streets by means of opaque fencing or masonry walls with suitable landscaping.

  • Joint Network Implementation and Grooming Process Upon request of either Party, the Parties shall jointly develop an implementation and grooming process (the “Joint Grooming Process” or “Joint Process”) which may define and detail, inter alia:

  • Curriculum Vitae (a) The Chief Librarian shall maintain a curriculum vita for each Librarian. It is the Librarian’s responsibility to ensure that the curriculum vita on file is kept current. Members shall prepare their curriculum vita with the advice and assistance of their Chief Librarian. Members may revise their curriculum vita at any time.

  • Curriculum Work Service on a District curriculum committee shall be required for grade level or department chairpersons. All other teachers working on such committee(s) shall be designated (in writing) by the Curriculum Director and shall be paid, at the hourly rate contained in Schedule B, for all documented hours of committee service (up to such limits as may be imposed by the District) occurring when school is not in session (e.g. during the summer), during duty-free lunch periods or preparation periods, and before/after the teacher’s regularly scheduled work day. Curriculum committee work shall occur at such times as are determined or approved by the Curriculum Director.

  • Alignment with Modernization Foundational Programs and Foundational Capabilities The activities and services that the LPHA has agreed to deliver under this Program Element align with Foundational Programs and Foundational Capabilities and the public health accountability metrics (if applicable), as follows (see Oregon’s Public Health Modernization Manual, (xxxx://xxx.xxxxxx.xxx/oha/PH/ABOUT/TASKFORCE/Documents/public_health_modernization_man ual.pdf):

  • Study Area The study area focused on the Bulk Power System in South-Eastern New York between Albany and New York City, and voltages underlying systems at 115 kV and above in the lower Xxxxxx Valley (Zones G, H & I). In the PSS™E power flow base case provided by NYISO, facilities rated at 115 kV and above in PSS™E designated areas 6 through 11 are monitored in the study. These areas are: • Capital District • Xxxxxx • Millwood • Xxxxxxxxx • Con Ed • Long Island

  • System Impact Study An assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights.

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