Document is current

Article History

First Online: 24 July 2017

Compliance with ethical standards

:

: Roberto Salvatori: Consultant/Advisory Board: Pfizer, Ionis Pharmaceutical, Novo Nordisk, Novartis; Research support: Ipsen, Novartis, Pfizer, Novo Nordisk, Chiasma, Millendo, Strongbridge, Prolor. Murray B. Gordon: Research support: Ipsen, Chiasma, Novartis, Novo Nordisk, Opko, Pfizer, Strongbridge, Teva. Whitney W. Woodmansee: Clinical trial investigator: Ipsen, Novo Nordisk, Versartis, Pfizer; Consultant/Advisory Board: Corcept, Genentech, Ipsen. Adriana G. Ioachimescu: Research support: Novartis, Ipsen, Chiasma, Pfizer; Consultant/Advisory Board: Chiasma, Ionis, and Ipsen. Beloo Mirakhur and David Cox: Full-time employees: Ipsen Biopharmaceuticals, Inc. Don W. Carver: Ipsen consultant. Mark E. Molitch: Research support: Ipsen, Novartis, Bayer, Prolor, Novo Nordisk, Johnson and Johnson; Consultant: Corcept, Ipsen, Novartis, Novo Nordisk, Merck, Pfizer.

: All eligible patients signed a statement of informed consent, and the day on which the informed consent form was signed was considered the enrollment date.

: 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 in studies 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.

: This article does not contain any studies with animals performed by any of the authors.