Main Study News
Since we started the main study we managed to reach 40 patients just before 2018 ended!
Patient number 40 was included in the study only 2 hours before the new year.
Well done everyone, let's keep up the good work and include more patients in 2019
A new version of the Protocol (v2.2 180413) has been sent to every participating site and we ask
site investigators to read it and sign at page 6.
There has been some restructuring of the text and our statistician has done some clarifications in the statisics chapter.
The new version can also be downloaded from our homepage. A newsletter has also been sent to participating sites.
The study is up and running and so far so good.
There has been some changes in some of our documents:
All of them are marked with a red text "new version" for at least one month so that you will know whats new.
FAQ is under construction still, and a news letter will arrive before summer.
Our initial plan to start the main study on the 15th of March 2018 has unfortunately been postponed until
15th of April.
The reason is that our work to complete “clean file” of the pilot phase has been delayed.
Also, some adjustments of the main study protocol are awaiting to be approved by the
Ethics Review Board. We know you are eager to start and I am sorry for this delay.
However, everything needs to be in place before we can start, which I hope you all understand.
Please contact me if you have any questions regarding this or any other issue.