The study was funded by an unrestricted grant from Schering AG. The authors would like express their appreciation to the members of the independent Advisory Council for their constructive criticism and unfailingly fair scientific discussion.

The authors would also like to highlight the contributions of numerous colleagues who were responsible for the field work in the individual countries.

They clarified data inconsistencies and missing data, validated patient-reported adverse events with patience, care, and tenacity, and their untiring commitment enabled a remarkably low loss to follow-up rate.

The authors' special thanks are due to Ms. Anita Aßmann, Dr. Sabine Möhner, and Dr. Peter Potthoff for set-up and maintenance of the complex study logistics and quality assurance system.

The authors also want to thank Ms. Marlene Schoofs for editorial support in preparing the manuscript.
The work of Dr. Stefan Binder, Dr. Hans-Werner Hillger, and Dr. Peter Nesseler in the blinded adjudication process for the reported VTE is also much appreciated.