{"certainAgreement":{"otherDetails":"The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.","piSponsorEmployee":false,"restrictionType":"OTHER","restrictiveAgreement":true},"limitationsAndCaveats":{"description":"All randomized patients were included in the FAS. Seven patients (4 in the everolimus arm \\& 3 in the placebo arm) were randomized but never received treatment \\& were therefore excluded from the Safety Set."},"pointOfContact":{"email":"trialandresults.registries@novartis.com","organization":"Novartis Pharmaceuticals","phone":"862-778-8300","title":"Study Director"}}