{"certainAgreement":{"otherDetails":"As a multicentre study, the first publication shall be based on consolidated analysed data from all centres, i.e. the publication of results from individual institution/Investigator is not allowed before the publication of the full study results.\n\nThe PI agrees to give the sponsor 60 days to review the communications. If case of propietary information inadvertenly divulged, intellectual property rights at risk or inaccurate information presented, changes can be required by the sponsor.","piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true},"limitationsAndCaveats":{"description":"Recruitment problems leading to smaller sample size than expected (70 patients vs 100). A priori, the impact on precision was considered acceptable (95% confidence interval equal to ± 10.0% with 100 patients vs ± 11.7% with 70 patients)."},"pointOfContact":{"organization":"Otsuka Pharmaceutical Europe Ltd.","phone":"+44(0)2037475000","title":"Medical Department"}}