Woodmansee, Whitney W.
Gordon, Murray B.
Molitch, Mark E.
Ioachimescu, Adriana G.
Carver, Don W.
Mirakhur, Beloo
Cox, David
Salvatori, Roberto
Funding for this research was provided by:
Ipsen Fund
Article History
Received: 1 November 2017
Accepted: 21 April 2018
First Online: 16 May 2018
Compliance with ethical standards
:
: WWW: Clinical trial investigator: Ipsen, Versartis; Advisor/consultant: Ipsen. MBG: Research support: Chiasma, Corcept, Ipsen, Novartis, Novo Nordisk, Pfizer, OPKO, Strongbridge, Teva. MEM: Research support: Bayer, Ipsen, Johnson & Johnson, Novartis, Novo Nordisk, Prolor; Advisor/consultant: Corcept, Ipsen, Merck, Novartis, Novo Nordisk, Pfizer. AGI: Research support: Chiasma, Ipsen, Novartis, Pfizer; Advisor/consultant: Chiasma, Ionis, Ipsen, Pfizer. DWC: Ipsen consultant. BM, DC: Full-time employees: Ipsen Biopharmaceuticals, Inc. RS: Research support: Chiasma, Novartis, Novo Nordisk, Pfizer, Prolor, Strongbridge; Advisor/consultant: Pfizer.
: The SODA study was conducted in accordance with the International Conference on Harmonization Good Clinical Practice Guidelines, current Food and Drug Administration regulations and guidelines, local ethical and legal requirements, and the United States Code of Federal Regulations and the Health Insurance Portability and Accountability Act for the collection, transmission, and storage of study data. All procedures performed involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
: Signed informed consent was obtained from each patient at study inclusion.