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Metabolic water production is estimated to represent on average approximately 250 to 350ml/day for sedentary persons ( EFSA 2010 ) but can increase up to 600 ml/day with strenuous physical activity ( Pivarnik and Palmer 1994 )

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Due to differences in the bioavailability of oral versus injectable formulations, further phase 3 trial evidence is needed to establish both efficacy and safety

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In Studies JMDB and JMCH, among patients who received vitamin supplementation, incidence of Grade 3 to 4 neutropenia was 15% and 23%, the incidence of Grade 3 to 4 anemia was 6% and 4%, and incidence of Grade 3 to 4 thrombocytopenia was 4% and 5%, respectively