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There was an increased incidence of Harderian gland adenomas in males and females in all treatment groups (starting at doses equivalent to 0.002 times the human 5 mg intravenous dose, based on body surface area, mg/m2)

The theoretical pathway exists, but clinical human studies have produced mixed results

Cloudiness indicates potential peptide aggregation, denaturation, or contamination

(v) If the quality measure is duplicative

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2 Certain bacterial and viral infections, such as ascending urinary tract infections, sexually transmitted infections, and viral mumps, can cause epididymitis and orchitis (inflammation of the testes) followed by atrophy and permanent testicular dysfunction