24-month use of once-weekly GH, LB03002, in prepubertal children with GH deficiency.

Background: Sustained-release GH formulations may provide a strategy for improving treatment compliance and persistence in GH-deficient patients.

Objective: The aim of the study was to examine efficacy and safety of LB03002, a sustained-release GH formulation for once-weekly administration.

Design: We conducted a phase III, 12-month, multinational, randomized, open-label, comparator-controlled trial with a 12-month uncontrolled extension.