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Whitby, Christopher A

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The registration is conditional on provision of a clinical study plan, as part of the Risk Management Plan (RMP), outlining planned confirmatory data collection within a maximum of 6 years post registration

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[41] Physical Cardiovascular side effects can include hypertension or hypotension from a vasovagal response, Raynaud's phenomenon (reduced blood flow to the hands and feet), and tachycardia (increased heart rate)

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