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The drug is strongly vasoconstrictive and has caused pronounced vasoconstriction (pseudoergotism), leading to ischemia and amputation of fingers and toes

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Ethics approval The study was conducted in compliance with the study protocol, the Declaration of Helsinki, the International Council for Harmonisation (ICH) Guideline E6 for Good Clinical Practice (GCP), the Food and Drug Administration (FDA) GCP Code of Federal Regulations Title 21 (part 56) and the European regulation EU 536/2014, including regulations relating to the protection of subjects personal data

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