Study Subjects. (a) The Investigative Site shall ensure that the rights and welfare of the Study Subjects are protected, and shall ensure that the Study is conducted in accordance with the ethical principles of the World Medical Association Declaration of Helsinki (as amended from time to time). A “Study Subject” or “Study Subjects” means a person (or persons) who, in accordance with the Protocol, is (or are): (a) eligible to be enrolled in the Study; and (b) enrolled in the Study.
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