Who will be blinded {17a}
RECURRENT DISEASE
The personnel assessing participants’ outcomes, like the microbiology laboratory staff or the sponsor medical expert discussing the possibility of recurrent disease, will remain blinded to treatment assignment throughout the whole study in order to ensure unbiased assessment of efficacy endpoints, in attribution of AE causality and expectedness, and in discussion on management with site staff. This is laid down in the trial protocol and associated documents; and data fields from the study database that show treatment assignment, will not be shared with those persons before formal database lock. The data analyst will not be blinded, which is required for composing unblinded reports to the DSMB.