Tracking Number:
Funding Opportunity Number:
Received Date:
Section 4 - Protocol Synopsis (Study )
4.1. Brief Summary
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18
4.2. Study Design
2
4.2.a. Narrative Study Description
3
18
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43
4.2.b. Primary Purpose
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4.2.c. Interventions
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2
Type
Name
Description
4.2.d. Study Phase
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2
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Is this an NIH-defined Phase III Clinical Trial?
4.2.e. Intervention Model
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2
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4.2.f. Masking
Participant
Care Provider
Investigator
Outcomes Assessor
4.2.g. Allocation
4.3. Outcome Measures
2
Type
Name
Time Frame
Brief Description
25
25
25
40
4.4. Statistical Design and Power
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2
4.5. Subject Participation Duration
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2
4.6. Will the study use an FDA-regulated intervention?
4.6.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status
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2
4.7. Dissemination Plan
❏
✔
Yes
Y: Yes
No
N: No
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