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We concentrate on the methods that have been designed in ELAN and which are useful for studying termination and normal forms of ELAN programs.
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The results revealed that no significant differences in survival were observed between groups, with approximately 98%% of the animals surviving to study termination.
A total of 71% of patients who discontinued prematurely were ongoing in the study for at least 6 months, but were discontinued due to study termination by the sponsor.
Despite the early study termination, over 750 women presented for interviews within a 4-week study period, and the majority of variables reached equilibrium prior to study termination.
Patients are to stay in the trial up to study termination.
Tumor volume defined as (length × width)/2 was measured every two days with a caliper up to study termination.
Though the target study size was 300 patients, concerns about ESA-associated mortality led to study termination after 70 patients were randomised.
Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination.
Treatment-related AEs leading to study termination of 4 patients in the TS were ocular in all cases in the FC treatment arm.
During the double-blind period, there were no TEAEs leading to study termination, no treatment-emergent serious adverse events (SAEs) and no severe TEAEs.
Written notification documenting the reason for study termination will be provided to the investigator by the terminating party.
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