Ethics approval and consent to participate
The following ethics committees approved the trial protocol and its amendments: Comité Consultatif sur le Traitement de l’Information en matière de Recherche dans le domaine de la Santé (Paris, France), Israelitisches Krankenhaus (Hamburg, Germany), University of Bologna (Bologna, Italy), Humanitas Hospital IRCS (Milano, Italy), Floraspe Renzetti Hospital (Lanciano, Italy), Agostino Gemelli University Hospital (Rome, Italy), University of Parma (Parma, Italy), University of Pisa (Pisa, Italy), University of Pescara (Pescara, Italy), Careggi University (Firence, Italy), University of Napoli Federico II (Napoli, Italy), University of L’Aquila (L’Aquila, Italy), University of Messina (Messina, Italy), University of Genoa (Genoa, Italy). Ospedale S. Maria di Ca′ Foncello (Treviso, Italy), Fondazione IRCCS Policlinico San Matteo (Pavia, Italy), Centro médico Teknon (Barcelona, Spain), Hospital Clínico San Carlos (Madrid, Spain), Hospital Universitario 12 de Octubre (Madrid, Spain), Hospital Germans Trias I Pujol (Badalona, Spain), Hospital de Bellvitge (Barcelona, Spain), Consorci Sanitari del Maresme (Mataró, Spain), Hospital Universitario Virgen de la Macarena (Sevilla, Spain), Hospital Universitari Doctor Josep Trueta (Girona, Spain), Hospital Universitari Sant Joan de Reus (Reus, Spain), National Institute for Health Research (London, UK).
Consent for publication
JT receives grants and/or research support from Abbott, Novartis and Shire; honoraria and/or consultancy fees from Almirall, AstraZeneca, Danone, GI Dyamics, GlaxoSmithKline, Ironwood, Janssen, Menarini, Novartis, Rhythm, Shire, Takeda, Theravance, Tsumura, Will Pharma and Zeria; and speaker fees from Abbott, Almirall, AstraZeneca, Janssen, Menarini, Novartis, Shire, Takeda and Zeria.
VS receives grants and/or research support from Alfa Wassermann, Almirall, Aptalis, Italchimici, Norgine, Shire, Takeda, Valeas; honoraria and/or consultancy fees from Abbott, Alfa Wasserman, Almirall, Angelini, Aptalis, CM&D Pharma, Farmaderma, Ironwood, Norgine, Shire, Takeda, Valeas, Vibrant and Zeria.
FM receives speaker fees from Almirall.
YY receives grants from Shire; Medtronic; and speaker fees from Almirall, Shire, and Sucampo.
PL receives financial support from Abbott / Solvay, Almirall, Aptalis / Axcan, Norgine, and Shire.
BC receives honoraria and/or consultancy fees from Almirall, Mundipharma, Mayoly Spindler, and Menarini.
MS receives unrestricted research grants from Danone, and AstraZeneca; consultant and/or Advisory Board member fees from Danone, Nestlé, Chr Hansen, Almirall, Albireo and Shire; participation fees for company-sponsored speaker’s bureau from Almirall, Shire, Tillotts and Takeda.
JM is an employee of TFS Develop S.L, contracted by Almirall S.A to conduct the study.
GW and AM are employees of Allergan International.
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