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Intravenous infusions and/or injections of more than a total of 100 mL per 12-hour period except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations

Symptoms of an allergic reaction to sulfa drugs include rash or hives, itchy skin or eyes, and swelling

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Additional sensitivity analyses, including three static anchor assessments and assumptions that early discontinuers were nonresponders, confirmed the robustness of these findings