Ethics approval and consent to participate
RECRUITMENT
The conduct of the trial adhered to the declaration of Helsinki and Good Clinical Practice Guidelines, and the ethical committees of all participating hospitals (ethics committees: Ethikkommission beider Basel EKBB (Reference Number 370/08), Ethikkommission der Kantone Aargau und Solothurn (Reference Number 2011/031), commission d’ethique Lausanne (Reference Number 116/10) and Ethikkommission Bern (Reference Number 193/11)), as well as the Swiss Agency for Therapeutic Products (SWISSMEDIC (Reference Number 2009DR3227)) approved the study protocol before patient recruitment. All patients provided written informed consent [This trial was registered with ClinicalTrials. gov, number NCT00973154 before the recruitment of the first patient. First posted: September 9, 2009. Last update posted: April 21, 2015 [