Haliduola, Halimu N.
Berti, Fausto
Stroissnig, Heimo
Guenzi, Eric
Otto, Hendrik
Sattar, Abid
Mansmann, Ulrich
Article History
Received: 22 April 2022
Accepted: 27 September 2022
First Online: 8 October 2022
Declarations
:
: The study was conducted in accordance with the protocol, the ethical principles derived from international guidelines including the Declaration of Helsinki, applicable International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines, New Zealand Medicines and Medical Devices Safety Authority (Medsafe) regulations, Australia Therapeutic Goods Administration (TGA) regulations, and all other applicable laws and regulations. In addition, the study was approved by two independent ethical committees: Southern Health and Disability Ethics Committee (New Zealand) and The Alfred (Australia). Informed consent was obtained from all participants or their legal guardian.
: Not applicable.
: HNH, HS, EG, and HO are employees of Alvotech Germany GmbH. FB is an employee of Alvotech Swiss AG. AS is an employee of Alvotech UK LTD. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.