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Study Completion visits were conducted at week 40 for Control group patients and after six unsupervised injections (week 32, 36 or 40) for the Test group.
There were no notable changes in serum lanreotide concentrations in either the Test or Control group patients from Baseline to the Interim and Study Completion visits (Table 3).
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For information regarding Academic Training for J-1 students 'after' program completion, visit the Office of International Services website.
The ECG tracings were also obtained on Day 8 and at the study completion visit.
At week 24, participants will attend for the primary RCT completion visit.
The ECG tracings were also obtained on Day 15 and the study completion visit.
In the Test group, one patient administered an unscheduled seventh unsupervised injection a day before the Study Completion visit, which was therefore rescheduled for a month later.
At 12 months or premature discontinuation (when a patient discontinued from the study early), the study completion visit was carried out.
Vital signs and clinical laboratory parameters (hematological, biochemical, and urinalysis) were obtained at screening, Day 1 (pre-dose), and at the study completion visit (Day 50 for Arm A, Day 43 for Arm B) for all subjects.
Treatment with laquinimod/placebo was discontinued at week 8 postrandomisation and a follow-up/study completion visit was conducted at week 12. Patients who discontinued study drug early (prior to week 8) were required to attend a follow-up termination visit within 4 weeks (28 days) of study drug discontinuation.
The patient (or partner) was declared qualified by a healthcare professional to administer unsupervised injections after a maximum of three training injections; The patient had received adequate treatment throughout the study as assessed by the healthcare professional at the Study Completion visit; The patient's disease control (assessed by evaluating plasma GH and IGF-1 levels) was maintained.
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