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Criteria for Discontinuing or Modifying Allocated Interventions
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The criteria for which a participant is withdrawn from the study are (1) the withdrawal of informed consent, (2) acute hospitalization, (3) the occurrence of events or diseases listed in the exclusion criteria, and (4) the occurrence of any intervention-related major safety issues. In case of the last-named criterion, the study will be discontinued.
Copyright and License information: ©2023 Julia Seinsche, Eling D de Bruin, Enrico Saibene, Francesco Rizzo, Ilaria Carpinella, Maurizio Ferrarin, Sarina Ifanger, Sotiria Moza, Eleftheria Giannouli. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 09.11.2023.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
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