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INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Clinical Trial Readiness (R21 Clinical Trial Not Allowed)

List of required information for application:

1. Project title: Provide a clear and concise title for your proposed project.

2. Project summary: Provide a brief summary of the project objectives, methods, and expected outcomes.

3. Research plan: Describe the specific aims, background, and significance of the proposed research.

4. Study design: Provide a detailed description of the study design, including the inclusion and exclusion criteria, intervention or diagnostic methods, and outcome measures.

5. Biomarker and clinical outcome assessment measures: Describe the biomarkers and clinical outcome assessment measures that will be developed and tested in the study.

6. Trial methods and recruitment strategies: Explain the novel trial methods and recruitment strategies that will be developed and tested to increase the likelihood of success for clinical trials in individuals with Down syndrome.

7. Co-occurring conditions: Describe how the project will define the presentation and course of the co-occurring conditions in individuals with Down syndrome.

8. Candidate therapeutics or diagnostics: Provide information on the candidate therapeutics or diagnostics that will be moved towards clinical trials for Down syndrome and its co-occurring conditions.

9. Budget: Provide a detailed budget for the proposed research project, including personnel, materials, and other expenses.

10. Timeline: Provide a timeline for the proposed project, outlining the key milestones and deliverables.

11. Team qualifications: Describe the qualifications and expertise of the research team members who will be involved in the project.

12. Dissemination plan: Explain how the research findings will be disseminated to the scientific community and the broader public.

13. Ethical considerations: Explain how the research will adhere to ethical guidelines and ensure the well-being and rights of the participants.

14. References: Include a list of relevant references cited in the application.

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