Kalvelage, Christina
Zacharowski, Kai
Bauhofer, Artur
Gockel, Ulrich
Adamzik, Michael
Nierhaus, Axel
Kujath, Peter
Eckmann, Christian
Pletz, Mathias W.
Bracht, Hendrik
Simon, Tim-Philipp
Winkler, Michael
Kindgen-Milles, Detlef
Albertsmeier, Markus
Weigand, Markus
Ellger, Björn
Ragaller, Maximilian
Ullrich, Roman
Marx, Gernot
Article History
Received: 20 March 2018
Accepted: 8 February 2019
First Online: 4 March 2019
Ethics approval and consent to participate
: Approval for the study has been obtained from the ethics committee responsible for the sponsor and from the responsible German federal agency (the <i>Paul-Ehrlich-Institut</i>) and from local ethics committees as appropriate. No invasive study procedure will be commenced if written informed consent to participate in the trial has not been obtained from the subject, a legal representative, a court-appointed carer or a study-independent consultant physician. A list of the ethics committees involved can be made available on request.Important protocol modifications will be made public on clinicaltrials.gov.
: Not applicable.
: AB and UG are employees of Biotest AG, manufacturer of Pentaglobin® (IgGAM). CK is an employee of the RWTH Aachen University. KZ has received various research stipends, honoraria and lecturer’s fees, including from Biotest AG. There are no other actual or potential competing interests.
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