Table 1 Criteria for proving symptoms and characteristic symptoms

New symptoms: the symptom is unfamiliar and has not been observed within the last year or during the run-in-period

Characteristic symptoms are defined as proving symptoms with a strongly individualistic character:

Study participant or study physician classify the symptom as new or unusual

Symptoms affecting the whole organism of one or more study participant

The study physician classifies the symptom as new in his final evaluation

Symptoms affecting different organs or organ systems of one or more study participant

A strong aggravation or modification of present (familiar) symptoms

Symptoms accompanying a variety of other symptoms

Present familiar symptoms that have disappeared during the proving (cure)

Symptoms that occur during the trial, which appear strange, peculiar or unique to one or more study participants

Familiar symptoms from the past or present that have been cured or strongly alleviated