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This improvement was seen throughout the study period, as shown by pulmonary function tests at weeks 2, 4, 8, and 12, and were supported by the secondary efficacy endpoints evaluating lung function, for example the morning and evening PEFR measurements.
Patients were assessed for efficacy (UPDRS) monthly for 6 months and then every 3 months, and for safety (liver function tests) at weeks 2, 3, 6, 9, and 12 months.
The first positive test was at week 53 (end of study visit for the initial trial and first dose in the extension study) and tests at weeks 65, 77, and 89 were also positive; tests from week 101 until the patient discontinued were negative.
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Seven of the gabapentin users and 10 who received the placebo sat for tests of attention, impulse-control and other brain functions before the start of the trial and at Week 4. The placebo patients tended to score lower on all the tests at Week 4, while those receiving gabapentin scored higher, indicating better mental functioning.
The glucose profiles during the meal tests at week 6 are shown in Fig. 1.
While all patients had to undergo pulmonary function testing (forced expiratory volume in one second [FEV1], carbon monoxide diffusing capacity [DLco]) prior to randomization and at Week 52 (or end of study), only subjects who started INH were required to have additional tests at Week 12, or more often depending on test results at Week 12 or in case of respiratory symptoms.
Sera from patients were collected for biomarker testing at weeks 0, 24 24 and 102.
Participants saw a physician and underwent lymphocyte subset and hematology/biochemistry testing at weeks 4 and 12 and then 12-weekly.
Amygdalar CRF overexpression increased anxiety-like behavior in the DW test at week eight, which was only partially prevented by escitalopram.
Forty Drosophila of each genotype (20 male and 20 female) were tested at week 3.
Tg and wt mice, treated with lithium or saline 0.9% were tested at week 5 of treatment in the reference memory version of MWM.
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