At Janssen, we believe that transparency of clinical trial data advances science and medicine. That is in the best interest of everyone who uses our medicines and of providers who prescribe them. As such, we support the overall principles of greater clinical trial data transparency, including registration and disclosure of clinical trial results in external registers, publication of results in peer-reviewed journals, and sharing of clinical study reports (CSRs), and participant data from clinical trials.

Registration and disclosure of results

Janssen publicly discloses information about its clinical trials in external public registers, such as www.ClinicalTrials.gov and the EU Clinical Trials Register.

Disclosure includes:

• Registering pharmaceutical clinical trials conducted with patients (from phase 1b through phase 4) on external registers in accordance with existing legislation.

• Upon receiving regulatory approval, disclosing clinical trial results in the form stipulated by local regulations and legislation and within the set deadline.

Publication of results in peer-reviewed journals

We endeavor to publish results from all company-sponsored clinical trials from phase 2 through 4 and from phase 1 trials with patients in peer-reviewed journals. Studies which are terminated early (prior to the prespecified study end date) are also published, provided that they yield scientifically or medically important results.

We are also prepared to publish pharmaceutical research of scientific or medical importance from discontinued clinical research programs and prospective observational studies, including registers, analyses of databases, economic health data, and end results of research programs.

Sharing clinical study reports (CSRs) and data

We appreciate and acknowledge that study participants (patients and researchers) who agree to participate in our clinical trials are vitally important partners in advancing medical knowledge. We are dedicated to upholding the commitments we have made with them, including patient privacy.

• Clinical study reports (CSRs) are official reports which provide a comprehensive description of the design, methods, and results of clinical trials.

• Participant data is data on each study participant which is collected at each visit or study contact. Analysable participant data is stored in databases which allow analysis by computer programs and statistical tests.

• We have an agreement with the Yale Open Data Access (YODA)-project to serve as the independent review panel for evaluation of requests for CSRs and participant data from researchers and physicians for scientific research for the advancement of medical knowledge and public health. For more information on this process or to make a request, please visit http://yoda.yale.edu.