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Page
One:
A. Title
B.
Primary
Investigator and
other
investigators
C. Date
D.
Department and
Institution
E.
Complete Address
and email
Attach
HIPAA and Human
Protection
Certificates of
each team member
Attach CV of
Primary
Investigator
Page
Two:
F. The Study
Protocol
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1.
SPECIFIC
AIMS
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Objectives
and
Research
Question
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Hypotheses
(H1 and
H0)
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2.
BACKGROUND
AND
SIGNIFICANCE
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Background
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3.
PRELIMINARY
STUDIES
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4.
RESEARCH
DESIGN AND
METHODS
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Design
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Timeframe
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Epidemiological
approach
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Sampling
design
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Variables
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Predictor
variables
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Outcome
variables
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Statistical
Issues
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Sample
size
estimation
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Analytic
approach
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5.
HUMAN
SUBJECTS
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Subjects
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Selection
criteria
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Consent
and/or
waiver
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6.
LITERATURE
CITED
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7.
ABSTRACT
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8.
LAY
SUMMARY
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9.
ONE
SENTENCE
SUMMARY
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10.
SHORT
TITLE
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11.
MOTIVATION
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