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Furthermore, as trauma is undoubtedly at the origin of PD and even micro-injuries may bear serious consequences in genetically predisposed patients, even injections must be considered a source of microtrauma for the tissues, therefore we made sure to use a very thin needle when performing the injections in the area around the plaque, and we decreased the number of injections at every treatment cycle

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Pharmacovigilance best practice is to train sites on seriousness triggers before enrollment and reinforce that incomplete information should never delay initial reporting when SAE criteria may be met

Acharya A, Das I, Chandhok D, Saha T