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Patients who terminated their participation prior to week 30 were asked to complete the study questionnaires as part of their early termination assessment.
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As mentioned above, the randomized-withdrawal endpoint included early termination assessments of patients who discontinued the study if they met the treatment failure criteria during the randomized-withdrawal period, and who were not assessed thereafter.
A pre-termination assessment (T1) was conducted approximately 1 3 hours prior to the procedure and prior to administration of anaesthetic.
The following were administered at the pre-termination assessment (T1): The VAS consists of a 10 cm line with the endpoints 0 ('no pain') and 10 ('worst pain').
Patients who discontinued the study attended an early termination (ET) assessment (data obtained at this visit were included in the visit 7/ET assessment) and a follow-up visit following a 1-week washout period (visit 8/FU).
If you are considering salary sacrifice, check your pension entitlement and how salary sacrifice will affect other benefits, such as statutory maternity pay, statutory redundancy and termination payments and Child Support Agency assessments.
Patients who discontinued for any reason attended an early termination visit, which included assessments scheduled for the last on-treatment study visit (9R).
The CAPS was used to establish a diagnosis of PTSD based on traumatic event exposure prior to termination and, at subsequent assessments, a diagnosis of PTSD secondary to the termination procedure.
For the repeated PSFS assessments at baseline and termination of treatment and (SPADI, SF-36) assessments at baseline, 12, 24 and 52 weeks a summary measure such as the Area Under the Curve (AUC) will be calculated for each patient.
Four studies (Linn, Wang, Faghri, and Baker) performed a follow-up assessment after the termination of FES treatment.
Four weeks later at termination this resulted in 16 assessments (t = 4).
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