Gremse, David
Gold, Benjamin D.
Pilmer, Betsy
Hunt, Barbara
Korczowski, Bartosz
Perez, Maria Claudia
Funding for this research was provided by:
Takeda Pharmaceuticals U.S.A.
Article History
Received: 3 July 2018
Accepted: 4 October 2018
First Online: 2 November 2018
Compliance with ethical standards
:
: Barbara Hunt and Maria Claudia Perez are employees of Takeda Development Center Americas, Inc., a wholly owned subsidiary of Takeda Pharmaceuticals U.S.A., Inc. Betsy Pilmer was employed by Takeda Development Center Americas, Inc., at the time of this study. David Gremse and Benjamin D. Gold were consultants for Takeda Pharmaceuticals of North America. Bartosz Korczowski has no relevant conflicts to disclose.
: The datasets generated and/or analyzed during the current study are not publicly available owing to protection of rights and safety of patients involved in the investigation (Title 21 CFR, Part 50).
: The informed consent and assent forms described the planned and permitted uses, transfers, and disclosures of the subject’s personal and personal health information for purposes of conducting the study, and further explained the nature of the study, its objectives, and potential risks and benefits. The informed consent and assent forms detailed the requirements of the participant and the fact that he or she was free to withdraw at any time without giving a reason and without prejudice to his or her further medical care. The date of informed consent/assent was recorded on the forms. The informed consent and assent forms were approved by both the institutional review board/independent ethics committees and the sponsor before use, and embodied the elements of informed consent and assent as described in the Declaration of Helsinki and the ICH Guidelines for GCP and were in accordance with all applicable laws and regulations.