Review by Joseph Ross – 07/02/2015 – 5:32pm

Data Request Number: 2015-0539 Please use this space to provide any comments, feedback or concerns (optional):

Applicant describes that data has also been requested from (GSK-led site) and from Shire Pharmaceuticals. Not clear how many additional data sources were requested, whether accounts will be able to be merged within SAS data sharing platform, or whether project could be successful if only data from NCT00866996 can be used.

Recommendation for this data request: Approve