Mental Health/Neuroscience

Consistent with the company's policy of public data disclosure, this results section includes result summaries of completed Lilly-sponsored observational / non-interventional studies conducted on Lilly- marketed products since September 1, 2007 at a minimum. The results of all studies conducted after initial product approval will be disclosed within one year of study completion.

Consistent with ICH E3 guidelines, Lilly will disclose the results that are specified in the study protocol, including safety and efficacy results that impact patient care and the use of our products. Also, Lilly discloses a comprehensive description of the study design and methodology for each study. Results will be disclosed regardless of whether they support the hypothesis being tested or are contrary to the predicted outcome. Results will be publicly disclosed as stated above, unless posting would compromise publication in a peer reviewed medical journal or contravene national laws or regulations. Results of studies that are under review by peer-reviewed journals that prohibit pre-publication disclosure will be posted on the registry after publication. Study results are also disclosed through presentations and abstract submissions at professional scientific meetings.

Included are study result summaries that are completed to date. The company will continue to disclose additional summaries and publication citations as they become available.

Summaries of study results are intended to report the results of the study that were known at the time of each study's completion. The information contained in these summaries is not intended to promote or otherwise commercialize (directly or indirectly) any off-label or unapproved uses of Lilly medicines, nor is it intended to provide a comprehensive analysis of all data currently available regarding a particular drug. In some cases, more current information regarding a drug, including post-hoc analyses and meta-analyses, may be available as part of the general body of scientific knowledge in forms such as manuscripts, abstracts, or posters.

Observational / Non-Interventional Studies on Lilly products may also be sponsored and reported by parties other than Lilly in other clinical trial registries.

Observational / Non-Interventional Study Results

The following studies have been conducted for products in the mental health/neuroscience therapeutic area.