Klek, Stanislaw http://orcid.org/0000-0002-7887-3464
Chambrier, Cécile
Cooper, Sheldon C.
Gabe, Simon
Kunecki, Marek
Pironi, Loris
Rahman, Farooq
Sobocki, Jacek
Szczepanek, Kinga
Wanten, Geert
Lincke, Nicole
Glotzbach, Bernhard
Forbes, Alastair
Funding for this research was provided by:
B. Braun Melsungen (No)
Article History
Received: 27 September 2019
Accepted: 12 December 2019
First Online: 30 December 2019
Ethics approval and consent to participate
: The study protocol was initially approved in its version 1.0 dated 11 October 2016 by the Ethics Committee of the Radboud University Medical Centre and the Centrale Commissie Mensgebonden Onderzoek (CCMO), Netherlands, (No. NL59956.091.17), and by the Ethics Committee of the University Hospital of Bologna, (No. 22/2017/O/sper) and the Agenzia Italiana del Farmaco (reference to European Clinical Trials Database No: 2015–000849-23), Italy. The Ethics Committee of the East Hospital Group Bâtiment Pinel – South-East III CPP, France, requested an amendment in the exclusion criteria (add exclusion criterion no. 16). The amended study protocol version 2.0, dated 20 June 2017 was approved by the French Ethics Committee (No. 2017–031 B) and the National Agency for the Safety of Medicines and Health Products (ANSM), France, (No. 170301A-42), and after initial submission in Poland by the Ethics Committee Regional Medical Association Kraków (No. 148/KBL/OIL/2017) and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (No. UR.DBL.BLE.4500.0276.2017.NK.1 1148/17). The substantial amendment was approved by the Ethics Committee of the University Hospital of Bologna on 20 September 2017, and by the Ethics Committee of Radboud University Medical Centre on 28 September 2017. The study protocol version 2.1, dated 11 November 2017 including non-substantial clarifications was initially approved by the London – Chelsea Research Ethics Committee and Health Research Authority (18/LO/0569), and the Medicines and Healthcare products Regulatory Agency (03551/0300/001–0001), UK. The study protocol in its current version 2.2, dated 5 November 2018 including one non-substantial change was notified to the Ethics Committee and Health Research Authority in the UK for confirmation of classification as non-substantial. The non-substantial changes do not impact the conduct of the trial.Written informed consent has been obtained from all patients before enrollment in the clinical trial.
: Not applicable
: SK received honoraria as a lecturer from Baxter, BBraun, Fresenius-Kabi, Nestle, Nutricia and Shire. CC declares conflicting interests with Baxter and BBraun. SC received educational sponsorship from Fresenius-Kabi/Calea and Shire/Takeda and honoraria from Baxter and Novartis. SG received consultancy honoraria and funding for conferences from Takeda and Shire. MK received honoraria as a speaker from Baxter, Fresenius-Kabi, and Shire. LP received an advisory board grant from Baxter, Fresenius-Kabi and Shire, and an educational grant from SEDA. FR declares that he has no competing interests. JS received honoraria as a lecturer from Baxter, BBraun, Fresenius-Kabi, Nestle, Nutricia and Shire. KS received honoraria as a lecturer from Baxter, BBraun, Fresenius-Kabi and Nutricia. GW received research grants from Fresenius-Kabi, Baxter, BBraun and Geistlich Pharma. AF is a member of the speakers’ bureau for Baxter, BBraun, Dr Falk Pharma, and Fresenius-Kabi. NL and BG are employed by B. Braun Melsungen AG.