Funding for this research was provided by:
Shire Development LLC
Text and Data Mining valid from 2018-04-27
Received: 21 May 2017
Accepted: 11 April 2018
First Online: 27 April 2018
Ethics approval and consent to participate
: The study protocol, the final approved informed consent document, relevant supporting information, and all types of subject recruitment information were submitted to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for each site, and approval was gained from the IRB/IEC and regulatory agency (if appropriate) prior to study initiation. Drug supplies were not released and subject recruitment did not commence until this written approval was received by the CRO. Shire and the IRB/IEC approved any amendments to the protocol prior to implementing changes in the study. The investigator was responsible for keeping the IRB/IEC informed of study progress and of any changes made to the protocol as deemed appropriate, in addition to reporting any serious and significant adverse events.This study was conducted in accordance with current applicable regulations, International ICH Good Clinical Practice and local ethical and legal requirements, and with the principles of the 18th World Medical Assembly (Helsinki 1964) and amendments of the 29th (Tokyo 1975), 35th (Venice 1983), 41st (Hong Kong 1989) and 48th (South Africa 1996) World Medical Assemblies, Declaration of Helsinki.The subject’s informed consent was mandatory for study participation and was obtained in writing. The subject’s informed consent was documented (on an appropriate form approved by the Ethics Committee) by the dated signature of the subject and investigator (investigator signature as required by IRB/IEC). To guarantee subject confidentiality, personal details and consent documentation was kept by the investigator in the subject file.
: MKW and AVJ were employees of Shire at the time of the study and analysis and were holding stock and/or stock options at Shire. GD has received financial support for research from AbbVie, Janssen Biologics, Given Imaging, MSD, Dr. Falk Pharma, and Photopill; received lecture fees from AbbVie, Tillotts, Tramedico, Ferring, MSD, UCB, Norgine, and Shire; and consulted for AbbVie, Actogenix, Centocor, Cosmo, Engene, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen Biologics, Millenium Pharmaceuticals, MSD, Novo Nordisk, PDL Biopharma, Pfizer, SetPoint, Shire, Takeda, Teva, and UCB. AY is an employee of Optum, which received funds from Shire Development LLC for data analyses and manuscript development.
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