Funding
Funding/Support: This study was sponsored by Prestige Biopharma Ltd.Role of the Funder/Sponsor: The funding source validated the study as designed by the trial’s steering committee, as well as subsequent amendments. The sponsor organized the management and the conduction of the study, including the collection of data. The data were analyzed by DICE with Drs Derde and Kaufman. The data were interpreted by the trial’s steering committee, including Drs. Pivot, Cox, Deforce, Feyaerts, and Derde, independently from the sponsor. The preparation of the manuscript was performed by Drs. Pivot and Derde and reviewed and approved by all enclosed authors. The sponsor approved the manuscript and agreed to submit the manuscript for publication.