Table 3 Organizational structure and responsibilities

Principal investigator and Research Physician

Sian Robinson, MB, BS; EDIC

Design and conduct of trial F.B.I., protocol preparation and revisions, preparation of Case Report Forms, managing Clinical Trials Office, publication of study reports,member of both committees, and organization of steering committee meetings.

Lead investigators

Sian Robinson, MB, BS; EDIC Odense University Hospital

Maintain trial master file and resolve contractual issues at sites

Stine Zwisler, MD, Phd

Svendborg Hospital

Karen Doris Boedker, MD SVS Esbjerg Hospital

Responsible for identification, recruitment, data collection, and completion of CRFs, along with follow-up of study patients and adherence to study protocol.

Steering committee

Sian Robinson, MB ,BS; EDIC

Agreement of final protocol

Aleksander Zincuk, MD

Reviewing progress of study

Ulla Lei Larsen, MD

Approving changes to the protocol

Claus Ekstrøm, PhD

Budget administration

Palle Toft, MD, DMSc

Advice for lead investigators

Trial management committee

Sian Robinson, MB ,BS; EDIC

Decide when site visit will occur

Stine Zwisler, MD, PhD

Data verification

Karen Doris Boedker, MD

Randomization

Aleksander Zincuk, MD

Provide annual risk report to Danish Health and Medicines

Ulla Lei Larsen, MD

Authority and Danish national scientific ethical committee

Claus Ekstrøm, PhD

Serious unexpected suspected adverse events (SUSAR) reporting

Palle Toft, MD, DMSc

Data manager

Azmir Salihovic

Maintenance of trial IT system and data verification

Data monitoring committee

Bjarne Dahler-Eriksen MD, PhD

Review the interim analysis.

Torben Bjerregaard Larsen, MD, PhD

Communicate the outcome of its deliberations to the Trial Steering Committee.

Helle Asboe Jørgensen MD, EDIC

Independent from the sponsor and the other committees.

Jacob von Bornemann Hjelmborg MSc, PhD