Verrips, Aad http://orcid.org/0000-0003-2163-1891
Dotti, Maria Teresa http://orcid.org/0000-0001-5731-5642
Mignarri, Andrea http://orcid.org/0000-0003-3516-7364
Stelten, Bianca M. L. http://orcid.org/0000-0003-0237-1406
Verma, Sue http://orcid.org/0000-0002-7275-881X
Federico, Antonio http://orcid.org/0000-0002-5246-1621
Funding for this research was provided by:
Leadiant Biosciences Ltd. (N/A)
Article History
Received: 4 October 2019
Accepted: 20 November 2019
First Online: 20 December 2019
Compliance with ethical standards
:
: Relevant and anonymised patient-level data and clinical study reports from both studies are available to appropriately qualified individuals upon reasonable request, providing that the proposed use of the data has been independently reviewed and approved. Data will be available immediately following publication, with no end date. Please contact Sue Verma (sue.verma@leadiantbiosciences.com) to request these data.
: Substantial contributions to study conception and design: AV, MTD, AM, BMLS, SV, AF; substantial contributions to analysis and interpretation of the data: AV, MTD, AM, BMLS, SV, AF; drafting the article or revising it critically for important intellectual content: AV, MTD, AM, BMLS, SV, AF; final approval of the version of the article to be published: AV, MTD, AM, BMLS, SV, AF.
: AV and AM receive honoraria from serving as a consultant for Leadiant Biosciences, Inc. (USA) and Leadiant Biosciences Ltd (UK). MTD and AF received honoraria for attendance at a meeting from Leadiant Biosciences Ltd (UK). BMLS declares to have no conflict of interest. SV is an employee of Leadiant Biosciences Ltd (UK).
: The study protocol, patient information leaflet and informed consent document were approved by the Independent Ethics Committee for both studies. The trials were designed and monitored in accordance with the ethical principles of the International Conference on Harmonisation, the Consolidated Guidelines on Good Clinical Practice, in accordance with the Declaration of Helsinki and following all other requirements of local laws. Written informed consent was obtained from all patients prior to inclusion in the studies.