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Adverse Reactions/Side Effects The following clinically significant adverse drug reactions are described elsewhere in the labeling: Drugs with Same Active Ingredient [see Warnings and Precautions (5.1)] Hypocalcemia and Mineral Metabolism [see Warnings and Precautions (5.2)] Renal Impairment [see Warnings and Precautions (5.3)] Osteonecrosis of the Jaw [see Warnings and Precautions (5.4)] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.5)] Musculoskeletal Pain [see Warnings and Precautions (5.6)] Patients with Asthma [see Warnings and Precautions (5.7)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice

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These factors represent a break in the bodys normal first line of defense and may indicate an infection

In the present study, no change was observed in the basal serum levels of folate, vitamin B12 and HCY among patients with VCD, those who recovered from the impairment, and those without impairment

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