Langford, Richard http://orcid.org/0000-0002-8703-067X
Viscusi, Eugene R. http://orcid.org/0000-0003-0260-4396
Morte, Adelaida http://orcid.org/0000-0002-3897-8966
Cebrecos, Jesús http://orcid.org/0000-0003-0238-8638
Sust, Mariano http://orcid.org/0000-0003-1908-9271
Giménez-Arnau, José María http://orcid.org/0009-0003-2675-4919
de Leon-Casasola, Oscar http://orcid.org/0000-0002-0837-9196
Funding for this research was provided by:
Esteve Pharmaceuticals
Article History
Accepted: 28 May 2024
First Online: 14 June 2024
Declarations
:
: This work was supported by ESTEVE Pharmaceuticals S.A.
: R.L. reports consulting and speaker fees from Avenue Therapeutics, BioQ Pharma, Camarus, Compass, Eli Lilly, Grünenthal GmbH, Grünenthal Ltd, GSK, Heron Therapeutics, MedinCell, Mundipharma, Pfizer, and Sintetica. E.R.V. reports consulting fees from ESTEVE Pharmaceuticals, Heron Therapeutics, Merck, Orion Pharmaceuticals, Salix Pharmaceuticals, and Vertex. A.M., J.C., M.S., and J.M.G.A. are employees of ESTEVE Pharmaceuticals. O.d.L.-C. reports personal fees for advisory board membership from ESTEVE Pharmaceuticals during the conduct of the study, and from ESTEVE Pharmaceuticals, Merck, and Stimgenics-Medtronic outside the submitted work.
: This was a pooled analysis of two previously reported clinical trials. Both studies were conducted in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines and received ethical approval.
: All patients provided written informed consent.
: Not applicable.
: ESTEVE Pharmaceuticals S.A. will consider requests for de-identified patient-level data and supporting study documents from qualified external researchers. Approval of requests will be at the discretion of ESTEVE Pharmaceuticals S.A. and will depend on the scientific merit of the proposed research and intended use of the data. If approval is granted, a Data Sharing Agreement must be signed and access to data will be provided only if ESTEVE Pharmaceuticals S.A. has legal authority to provide the data and there are no contradictory requirements relating to regulatory filings or reviews. Proposals should be sent to esteve@esteve.com.
: R.L., E.R.V., A.M., J.C., M.S., and O.d.L.-C. conceived or designed the studies. J.C. contributed to data collection. R.L., E.R.V., A.M., J.C., M.S., J.M.G.A., and O.d.L.-C. contributed to data analysis and/or interpretation. All authors drafted, edited, and/or reviewed drafts of the manuscript, and all approved the final version, and agree to be accountable for the accuracy and integrity of the work.