Sample Size and Centres

This project will recruit as many participating institutions as possible across the 30 European
countries represented by the ESA Council. It is planned to recruit about 5,000 patients over a
12-week observation period, including weekends and after-hours.

It is anticipated that at least 200 centres will be needed to achieve the target of patients during a 12-week period taking place from 01 April to 30 June (except for a few designated centres). Extra period of recruitments will be planned at a later stage. Local and national coordinators will ensure that all participating centres in their country have access to, and are familiar with, the protocol.