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Larsen TM, Toubro S, van Baak MA, Gottesdiener KM, Larson P, Saris WH, et al

The circumference of the swelling as well as hematomas and erythema resulting from the injury were observed on a scale from 0 to 3, where 0 means no injury and 3 means severe injury

The agency says it has only limited safety information for the proposed methods of administration and cannot determine whether the compound would harm humans