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In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions

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We are not finalizing our proposal to revise paragraph (b)(5)(iv) (which we proposed to redesignate as paragraph (b)(4)(iv)) to remove the reference to “paragraphs (c)(3)(ii) through (c)(3)(iv)” and add in its place the reference to “paragraphs (c)(3)(ii) and (c)(3)(iii)”