Heukelbach, Jorg http://orcid.org/0000-0002-7845-5510
Wolf, Doerte
Clark, John Marshall
Dautel, Hans
Roeschmann, Kristina
Funding for this research was provided by:
Pohl-Boskamp GmbH & Co. KG (n/a)
Article History
Received: 25 April 2019
Accepted: 20 September 2019
First Online: 18 October 2019
Ethics approval and consent to participate
: The clinical trial was approved by the Ethical Review Board of the Landesärztekammer Thüringen/Germany and by the German Federal Institute for Drugs and Medical Devices (BfArM) by the department for medical devices for the test product, and the department for medicinal products for the reference product, respectively. All participants were undertaken an informed consent procedure and signed the informed consent form (ICF). As children that participated in this study were unable to provide legally binding consent, the legal representative/s of all minor participants had to give informed written consent on his/her behalf prior to enrolment in the trial, and after having been informed about all details concerning the trial (patient information and informed consent from). Furthermore, age appropriate consent forms were used for children aged 7–11 year, and adolescents aged 12–17 years. All minors included in this trial provided written or verbal assent, according to age, witnessed by the parent or guardian.
: Not applicable.
: KR is an employee of Pohl-Boskamp and was involved in drafting the manuscript, revising it critically for important intellectual content, ensuring that questions related to accuracy and integrity of the work are resolved. Pohl-Boskamp engaged the CRO CardioSec Clinical Research GmbH to design and perform the clinical trial. Principle investigator was DW, who is managing director of CardioSec Clinical Research. Pohl-Boskamp provided salaries to JC and HD on a work-for-hire basis and remunerated the CRO CardioSec Clinical Research GmbH for their services in performing the study. DW is a company member of CardioSec Clinical Research GmbH without any financial or personal interest in the test product. JH has been an independent scientific consultant to Pohl-Boskamp GmbH & Co. KG.