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However, several combination therapies revealed excessive adverse effect and bad tolerability [ 38] or were not improving effect of single drugs [ 39].
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Routine laboratory parameters (see above), immunological parameters (see above) and estimation of tolerability (bad, moderate, good, excellent) by the subjects were documented every 4 weeks always in the morning to the same time (± 1 hour) as baseline investigations.
Furthermore, the global tolerability of the treatment (bad, satisfactory, good, very good) was assessed by the investigators at the last study visit.
Safety was assessed by medical examination, pulse rate, blood pressure, ECG, clinical and laboratory parameters, AEs, and an assessment of clinical global tolerability (4-point scale: good, satisfactory, not satisfactory, and bad).
Lastly, tolerability was rated on a 4-point scale (very good, good, poor, or bad) by both the investigators and the patients.
Tolerability and efficacy were assessed.
Phase I trials are planned to assess safety and tolerability.
The drug's safety and tolerability has already been tested on 47 healthy volunteers.
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