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Authors
Antoniotti, Carlotta
Borelli, Beatrice
Rossini, Daniele
Pietrantonio, Filippo
Morano, Federica
Salvatore, Lisa
Lonardi, Sara
Marmorino, Federica
Tamberi, Stefano
Corallo, Salvatore
Tortora, Giampaolo
Bergamo, Francesca
Brunella, Di Stefano
Boccaccino, Alessandra
Grassi, Elisa
Racca, Patrizia
Tamburini, Emiliano
Aprile, Giuseppe
Moretto, Roberto
Boni, Luca
Falcone, Alfredo
Cremolini, Chiara
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Article History
Received: 20 February 2020
Accepted: 12 July 2020
First Online: 22 July 2020
Ethics approval and consent to participate
: The protocol is conducted in accordance to the standards of Good Clinical Practice, in agreement with the principles laid down by the 18th Word Medical Assembly (Helsinki 1964) and subsequent amendment (Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996, Edinburgh 2000).The protocol version 1.2 (6th October 2017) was approved on 20th September 2018 by the Ethics Committee of Coordinating Center (Comitato Etico Area Vasta Nord Ovest, CEAVNO) and by the local Ethics Committees of participating centers. The list is provided as Additional fileInternalRef removed. Then, the study was amended in order to regulate additional tissue, blood and faecal samples collection and the protocol version 2.1 (19th February 2019) was approved on 13th June 2019 by the Ethics Committee of Coordinating Center (Comitato Etico Area Vasta Nord Ovest, CEAVNO) and by the local Ethics Committees of participating centers.All candidate study participants provide their written informed consent to study procedures after careful explanation by their treating investigators.
: Not Applicable.
: None declared.
