ELIGIBILITY CRITERIA INCLUSION-EXCLUSION CHECKLIST

PARTICIPANT ID
SITE	SITE NUMBER
VISIT TYPE	☐ Screening ☐ Baseline	DATE

Answer each of the criteria by checking the box marked Yes or No. A subject is eligible if they meet all of the inclusion criteria and do not meet any of the exclusion criteria. Add supporting documentation, as relevant, to this form.

Participant must answer YES to all inclusion criteria to be included in study:

#	INCLUSION CRITERIA	SOURCE / COMMENTS	MEETS CRITERIA Yes / No	INITIALS & DATE of Verifying Staff
1	☐ Yes	☐ No
2	☐ Yes	☐ No
3	☐ Yes	☐ No
4	☐ Yes	☐ No
5	☐ Yes	☐ No
6	☐ Yes	☐ No
7	☐ Yes	☐ No
8	☐ Yes	☐ No

Participant must answer NO to all exclusion criteria to be included in study:

#	EXCLUSION CRITERIA	SOURCE / COMMENTS	MEETS CRITERIA Yes / No	INITIALS & DATE of Verifying Staff
1	☐ Yes	☐ No
2	☐ Yes	☐ No
3	☐ Yes	☐ No
4	☐ Yes	☐ No
5	☐ Yes	☐ No
6	☐ Yes	☐ No
7	☐ Yes	☐ No
8	☐ Yes	☐ No

Did the participant meet the eligibility requirements for this study?	☐ Yes ☐ No

Print Name and Title of Verifying Research Staff Member	Signature of Verifying Research Staff Member	Date

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