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If the answer to Question 1 is affirmative, what characteristics of the patient, the disease, or the treatment regimen reliably predicts a favorable or unfavorable health outcome?

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In Study 1, the hemoglobin target was achieved by 72% (95% CI: 62%, 81%) of the 90 patients treated with Aranesp ä and 84% (95% CI: 66%, 95%) of the 31 patients treated with Epoetin alfa.

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Anaemia in HIV-infected pregnant women receiving triple antiretroviral combination therapy for prevention of mother-to-child transmission: a secondary analysis of the Kisumu breastfeeding study (KiBS).

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Explanations for the decrease in the number of transfusions include limiting the volume of blood tests, the utilization of a smaller volume of blood to perform these tests, the use of noninvasive means of assessing oxygenation and ventilation (pulse oximetry and transcutaneous monitoring), the use of erythropoietin therapy, and the adoption of various restricted transfusion criteria.

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Few studies have examined the pattern of change over time, so the extent to which people recover function that declines during treatment is not known.

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Novel erythropoiesis stimulating protein (NESP), also called darbepoetin alfa (Aranesp), lasts longer in the blood than epoetin alfa and requires fewer injections.

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In contrast, glycosylated biologics and biosimilars, which are considered comparable but distinct from a previously approved product with the same amino acid sequence, receive the root INN of the reference product plus a Greek letter suffix to indicate different glycosylation patterns.

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It should be noted that the terms comparable, similar and highly similar are specific terms used by the EMA and the FDA for the above mentioned purposes (see the FDA website), and so care should be taken in their use; see below.

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