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See Deschamps , supra note 3, at 103.

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Id., at 4.

See Guideline , supra note 1, at 20–22, 35–38.

Id., at 20.

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Id., at 35.

Id., at 36.

Id., at 37.

See Guidance for Industry, supra note 26, at 49.

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See Guidance for Industry, supra note 26, at 56.

See Guideline , supra note 1, at 42.

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See Guideline , supra note 1, at 19–20.

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See Florencio Ramanathan , supra note 46.

Id., at 120.

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Id., at 375; personal communication with author, January 10, 2006.

Id., at 373.

See Sykes , supra note 42, at 1103.

See Spellecy , supra note 52, at 374.

Id., at 375.

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