For Informations regading the Study Protocol details, go to “Study - Study Protocol”

A list of all participating study sites can be found at “Study - Participating Centers”

All Information concerning Data Entry, the Case Report Form (CRF), printed and electronic Data Management can be found at “Database & CRF”

All Study associated Documents are listed in the menu “Files & Documents”

Frequently Asked Questions (FAQ) and a Discussion Board can be found at “FAQ & Discussion”

The trial has been registered at clinicaltrials.gov

The Study Protocol has been published in Trials and is downloadable via Pubmed or Trials Biomed Central