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3 March 2010
It is the intent of H. Lundbeck A/S to publish the results of clinical trials sponsored by H. Lundbeck A/S and its fully-owned affiliates (referred to jointly hereafter as Lundbeck) in, for example, peer reviewed journals, abstracts, posters, and other presentations at scientific meetings.
This site (www.lundbecktrials.com) has been constructed by Lundbeck and is intended to serve as a registry, with publicly available lists of Lundbeck-sponsored trials, using the Lundbeck trial number as the unique trial identifier. For each trial ongoing as of 27 September 2007, there is a link to the trial registration at www.ClinicalTrials.gov.
For products marketed and actively promoted by Lundbeck, the results of trials completed after 1 January 2000 will be disclosed.
Posting of phase II-IV trials will be done no later than 21 days after first patient first visit. We strive to have a trial posted when seeking ethical approval. Phase I trials of subjects suffering from the disorder under investigation will also be posted within 21 days of first patient first visit.
For completed clinical trials with marketed products, Lundbeck will disclose clinical trial results either within 1 year after trial completion or within 30 days of FDA or EMA approval, whichever is later.
When it is necessary to inform investors, Lundbeck will first disclose clinical trial results of any one trial via a press release to the Stock Exchange before posting the trial results on the Lundbeck Clinical Trial Registry.
Exceptionally, public disclosure may be delayed if it would compromise intellectual property rights, an ongoing regulatory application, or confidentiality provisions in agreements with other parties.
Access to the Registry is unrestricted upon the acceptance of terms and conditions.
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