The main reasons for which protocols had to be modified after approval were a change in the number of subjects to be included (18%), a modification of inclusion criteria, a modification of the timetable and changes in examinations and treatments (Table 5).
The online assessment was simply the paper-based examination paper typically administered in this course translated to an online version, with no real change in examination techniques.
There were no changes in neurological examination or electrophysiological testing serially.
Safety assessments included adverse event (AE) reporting, changes in physical examination findings, clinical laboratory test results and vital signs at all visits.
Adverse events are defined as abnormal test findings, clinically significant symptoms and signs, changes in physical examination findings or hypersensitivity.
No major changes in physical examination or in standard laboratory parameters were observed after treatment.
Therefore, the changes in the examination costs, shifting from a film-based system to a filmless system, are unclear.
27 Responses were based on changes in physical examination and CBC and were classified as excellent in three patients, good in eight, and slight in nine.
No clinically significant changes in physical examination, vital signs, or lab parameters were observed during the study in either of the study groups.
The safety analysis, performed on the safety group, monitored the following: the course of adverse events, laboratory data, vital signs, and changes in physical examination.
