Several factors have caused delays in the work on the project. One important factor is that procedures for approval from ethical committees and institutional review boards have become much more demanding and time consuming during the last couple of years. In addition, one of the clinical studies was delayed due to the need for a pilot investigation before launching the main study.
A 12 months' extension will allow the collaborative to complete the clinical studies and submit the listed deliverables. The extension will also facilitate the final process of tying the different parts of the project together and submitting the planned scientific publications within the project period.
