Author Contributions: Dr Berthold had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Berthold, Bulitta.
Acquisition of data: Berthold, Unverdorben, Degenhardt, Bulitta.
Analysis and interpretation of data: Berthold, Bulitta, Gouni-Berthold.
Drafting of the manuscript: Berthold, Gouni-Berthold.
Critical revision of the manuscript for important intellectual content: Unverdorben, Degenhardt, Bulitta.
Statistical analysis: Berthold, Bulitta.
Obtained funding: Berthold, Bulitta.
Administrative, technical, or material support: Unverdorben, Degenhardt, Gouni-Berthold.
Study supervision: Berthold.
Financial Disclosures: None reported.
Funding/Support: This study was sponsored by Madaus AG, which also provided funding of the contract research organization involved. Neither Madaus AG nor any of their subsidiary companies manufactures or distributes any lipid-lowering drugs, including statins.
Role of the Sponsor: Employees of Madaus AG contributed to the design of the study. The study was conducted by support from the contract research organization, Clinical Research Management Pharmaberatung GmbH. The sponsor had no influence on the interpretation of the data or the writing of the manuscript.
Independent Statistical Analysis: An independent statistical analysis was conducted by Walter Lehmacher, PhD, from the Institute for Medical Statistics, Informatics, and Epidemiology, University of Cologne, Cologne, Germany. Dr Lehmacher reviewed a draft of the manuscript and had complete access to the original data. Using the same nonparametric test of Jonckheere and Terpstra (JT test) as the authors, Dr Lehmacher arrived at the same results. No remuneration was paid for his services.
Study Group:Germany: H.K. Berthold, MD, PhD, Rotenburg (n = 30 patients), E. Bönninghoff, MD, Beckum (n = 40), R. Erbel, MD, Frankfurt (n = 8), E. Jähnchen, MD, Bad Krotzingen (n = 9), U. Julius, MD, Dresden (n = 13), W. Köster, MD, Freiburg im Breisgau (n = 10), I. Naudts, MD, Dudenhofen (n = 30), M. Ritter, MD, Ibbenbüren (n = 4), I. Urlea-Schön, MD, Siegen (n = 21), B. Hinkelmann, MD, Kuppenheim (n = 15), S. Mantz, MD, Offenbach (n = 10), A. Schmidt, MD, Offenbach (n = 10), P. Franz, MD, Berlin (n = 5), R. Van der Meij, MD, Hagen-Hohenlimberg (n = 10).
Acknowledgment: We thank Michael Schäfer, MD, Uwe Phillip Strauss, MD, and Reinhold Sieck, PhD, all employed by Madaus AG, who helped in planning the trial. We are indebted to Karin Thiele, Dipl-Phil, Anke Brühl, PTA, and Ursula Schäfer, MD, all freelance collaborators of the contract research organization, for monitoring the trial, and Claudia Krapf, employed by the principal investigator's research institution, for technical assistance. Additional thanks to W. Strösser, MD, consultant for Madaus AG, for helpful discussions. All of the named persons received compensation from the funding sponsor with the exception of Mrs Krapf, who received no compensation.