Publication of Clinical Trial Information in Clinical Trials Registry and Results Websites

Bayer Healthcare is committed to proactively disclose information about its clinical trials in humans.

In addition to this website

• Bayer registers information on clinical trials on ClinicalTrials.gov for phase II- IV studies and trials testing effectiveness in serious or life threatening diseases.
• Results of Bayer sponsored clinical trials in phase II, III and IV are posted on ClinicalStudyResults.org if such trials have been conducted on Bayer’s drugs that are approved for marketing and are commercially available in the United States.

Access to this information is unrestricted and free-of-charge.

Bayer posts, in general, summaries of clinical studies that have been completed after July 1, 2005 and in the future within 12 months of the study completion date or upon first marketing.

There may be a delay in posting complete summaries of clinical study reports because Bayer may seek intellectual-property protection or comply with policies of peer-reviewed journals to which manuscripts have been submitted for publication. Further, Bayer may be required to withhold certain summaries of clinical study reports to comply with confidentiality provisions in agreements with other parties.

The content of the summaries conforms to the principles required by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Industry: Structure and Content of Clinical Study Reports (ICH’s E-3 Guidance).

Questions concerning Bayer’s registry should be directed to clinical-trials-contact@bayerhealthcare.com.