Lewis, James H. http://orcid.org/0000-0002-6686-3744
Cottu, Paul H.
Lehr, Martin
Dick, Evan
Shearer, Todd
Rencher, William
Bexon, Alice S.
Campone, Mario
Varga, Andrea
Italiano, Antoine
Article History
First Online: 27 June 2020
Compliance with ethical standards
:
: This study was supported by Context Therapeutics. Context Therapeutics was involved in all aspects of the study (design and conduct of the study; collection, management, analysis, and interpretation of data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication).
: James H. Lewis has no conflicts of interest that are directly relevant to the content of this article. Alice S. Bexon received payment as a medical writer. Todd Shearer is a paid consultant to Context Therapeutics and was compensated for his time performing pharmacokinetic analyses. William Rencher is a paid consultant to Context Therapeutics. Evan Dick and William Rencher are stock owners of Context Therapeutics. Martin Lehr is the CEO and stock owner of Context Therapeutics. Paul H. Cottu, Mario Campone, Andrea Varga, and Antoine Italiano were the principal investigators for the clinical trials and received salary support from BioTrial, the contract research organization that managed the phase I–II trials.
: The datasets generated during and/or analyzed during the current analysis are not publicly available because access to pharmacovigilance data must always be considered in respect to European Union laws, which protect the patient’s rights to personal privacy. This does not alter our adherence to <i>Drug Safety</i> policies on sharing data and materials, as upon reasonable request, the data may be made available by contacting the authors.
: This observational analysis was based on safety data extracted from a safety database. Clinical trial registration and ethical approval were not required for this analysis. This article also does not contain any data from animal studies performed by any of the authors.
: Cumulative safety data from a European safety surveillance database were summarized in this observational analysis. No identifying patient information was reported; therefore, no additional informed consent was required.