HIGHLIGHTS
SUMMARY
Methods/Desing Objectives Primary objectives 1. Trial Design This is a Spanish multicenter, investigator-driven, randomized, open-label, two-arm, clinical trial with a 24-month follow-up in patients with a first deceased donor or living donor KT who have BL at the time of the third-month protocol biopsy. Subject withdrawal criteria If the study is interrupted for any reason, the patient will be considered to have discontinued treatment prematurely and will only be included in the "intention to treat" (ITT) analysis and will be eliminated from the "per protocol" (PP) analysis . . .
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