As provided for in Article 3 of the Research Funding Agreement, the Sponsor and Chief Investigator will submit the safety information requested on the 'Clinical Serious Adverse Event Report' form (FRM-09210, Version 9.0) to the identified Janssen Pharmaceuticals Inc. representative of the country of origin, (i.e., Drug Safety Department of Janssen-Cilag Ltd) either by fax 01494 567799, or secure email and pdf to "Dsafety@its.jnj.com". For additional support, the Janssen-Cilag Ltd Drug Safety Department can be contacted on 01494 567 447.