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Authors
Gardin, Anne
Shakeri-Nejad, Kasra
Feller, Andrea
Huth, Felix
Neelakantham, Srikanth
Dumitras, Swati
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Funding
Funding for this research was provided by:
Novartis Pharma AG
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More Information
Article History
Received: 12 March 2019
Accepted: 20 July 2019
First Online: 7 August 2019
Compliance with ethical standards
: The study was conducted at two centers namely, SeaView Research, Inc., Miami, Florida, USA and SeaView Jacksonville, LLC Jacksonville, Florida, USA. The study protocol and subject consent forms were reviewed and approved by the Schulman Institutional Review Board, Cincinnati OH, USA. The study was conducted according to the ethical principles of the Declaration of Helsinki [CitationRef removed] and designed in compliance with the FDA guidelines for industry on Drug Interaction Studies-Study Design, Data Analysis, Implications for Dosing and Labeling Recommendation [CitationRef removed].
: Anne Gardin, Andrea Feller, Felix Huth, Srikanth Neelakantham, Swati Dumitras, and Kasra Shakeri-Nejad are employees of Novartis.
: 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.
: Informed consent was obtained from all individual participants included in the study.
