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If a situation is inconsistent with the requirements, the MAH and contract manufacturer should rectify the issues within one year

Taylor 2011)

Also, I was not seeing a high level of change in my shoulder pain & movement

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Mild side effects and potential risks, which should be referred to a doctor if they persist or worsen, include: pain, redness, or itching at the site of the injection mild diarrhea swelling sensation in the body More serious side effects, which require immediate medical attention, include: muscle cramps irregular heartbeat unusual weakness or tiredness swelling of the ankles or feet Severe reactions are very rare but require emergency intervention

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