New symptoms: the symptom is unfamiliar and has not been observed within the last year or during the run-in-period
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Characteristic symptoms are defined as proving symptoms with a strongly individualistic character:
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Study participant or study physician classify the symptom as new or unusual
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Symptoms affecting the whole organism of one or more study participant
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The study physician classifies the symptom as new in his final evaluation
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Symptoms affecting different organs or organ systems of one or more study participant
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A strong aggravation or modification of present (familiar) symptoms
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Symptoms accompanying a variety of other symptoms
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Present familiar symptoms that have disappeared during the proving (cure)
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Symptoms that occur during the trial, which appear strange, peculiar or unique to one or more study participants
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Familiar symptoms from the past or present that have been cured or strongly alleviated
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