Violari, Avy http://orcid.org/0000-0002-9437-776X
Masenya, Maysseb
Blanche, Stephane
Vanveggel, Simon
Hufkens, Veerle
Chetty, Polan
Opsomer, Magda
Funding for this research was provided by:
Janssen Pharmaceuticals
Article History
Accepted: 5 December 2020
First Online: 24 December 2020
Declarations
:
: This study was sponsored by Janssen.
: Avy Violari is a Data and Safety Monitoring Board member for study TMC114IFD3001, but has no commercial interests with Janssen. Maysseb Masenya and Stephane Blanche have no conflicts of interest to declare in relation to the DIANA study. Simon Vanveggel, Veerle Hufkens, Polan Chetty and Magda Opsomer are all full-time employees of Janssen and potential stockholders of Johnson and Johnson.
: The study protocol and amendments were reviewed by an Independent Ethics Committee/Institutional Review Board (IEC/IRB). This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
: Patients (where appropriate, depending on age) and their parent(s) or legal representative(s) had to sign the informed consent form voluntarily.
: All authors made the decision to submit the manuscript for publication.
: The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at ExternalRef removed. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at ExternalRef removed.
: Not applicable.
: Avy Violari was an investigator in the trial and reported data for those patients. Simon Vanveggel, Veerle Hufkens, Polan Chetty, and Magda Opsomer were involved in the data analyses. All authors were involved in the development of the primary manuscript and interpretation of data, have read and approved the final version, and have met the criteria for authorship as established by the International Committee of Medical Journal Editors (ICMJE).