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23.
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26.
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31.
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32.
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34.
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Kapp, supra note 24.
43.
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44.
21 C.F.R. § 314.26(b)(2) (1991).
45.
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48.
“Guidelines for the Conduct of Clinical Trials,”supra note 46.
49.
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“Guidelines for the Conduct of Clinical Trials,”supra note 46.
51.
21 C.F.R. § 314.26(b)(2)(iv) (1991).
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