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But when it came time for a new record, he realized those stripped-down recordings from more than 22 years ago represented the best of what he had to offer

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AEs are defined by the Italian Legislative Decree 211/2003 as any harmful clinical event that occurs in a patient or in a person involved in a clinical trial that has been given a medicinal/device product and does not necessarily have a causal relationship with this treatment. Indeed, ADRs are defined as follows: all untoward and unintended responses to an investigational medicinal product related to any dose administered. The definition also covers medication errors and uses outside what is foreseen in the protocol, including misuse and abuse of the product (Directive 2001/83/EC, Ministerial Decree 30 April 2015-GU No

28 Fiore, M