Sivakumar, Gnanamurthy
Magdum, Shailendra http://orcid.org/0000-0002-6830-3695
Aquilina, Kristian http://orcid.org/0000-0001-7015-5196
Kandasamy, Jothy
Josan, Vivek
Ilie, Bogdan http://orcid.org/0000-0001-6493-9103
Barnett, Ellie
Kocharian, Richard http://orcid.org/0000-0002-4142-4489
Pettorini, Benedetta
Article History
Received: 15 February 2024
Accepted: 27 April 2024
First Online: 10 May 2024
Declarations
:
: The trial was conducted in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (2016); the Declaration of Helsinki (2013); the European Union Clinical Trial Directive (2001/20/EC, May 2001); and the EU GCP Directive (2005/28/EC). Approval from the Office for Research Ethics Committees Northern Ireland, Lisburn, UK, was obtained prior to commencing the trial. Original clinical trial application approval was obtained from UK MHRA on 12 June 2014.
: Study subjects were children younger than 18 years requiring elective or emergent craniotomy or craniectomy for an infra- or supratentorial procedure. Per local regulations, the subject’s parent or legal representative provided informed consent; assent was obtained from subjects who possessed the intellectual and emotional ability to comprehend the trial’s concepts.
: All participating institutions were in receipt of financial compensation from Ethicon, Inc. for the work conducted for this research study. All investigators were required to complete a Financial Disclosure. B Ilie, E Barnett, R Kocharian are employees of Ethicon, Inc. E Barnett and R Kocharian receive stock options as part of employment with ETHICON. The authors have/do not have other competing interests to declare that are relevant to the content of this article.