Text and Data Mining valid from 2019-02-14
Accepted: 17 January 2019
First Online: 14 February 2019
Compliance with ethical standards
: FH, CK, JP, and TI are employees of Janssen Cilag. HdF, SL, TPP, employees of Mapi, and MH, employee of Mapi at the time the study was conducted, were paid consultants to Janssen Cilag. BN and AJL were external paid consultants to Mapi.
: 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. Ethics approval for the valuation study was granted by the US Salus Institutional Review Board (Austin, TX, registration numbers IRB00006833 (Board 1), IRB00006834 (Board 2), and IRB00009473 (Board 3)).
: Written informed consent was obtained from all individual participants included in the study.