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Clearly, high grades of evidence 19 could not be provided based on case reports and retrospective studies describing a few, rare and scattered paediatric patients with hyperammonaemia requiring dialysis

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Concerned that the positive trials might have occurred by chance and the amount of countervailing evidence, the FDA rejected the New Drug Application from the sponsor 4 times (Organon in 1999, 2002, and 2004, and Fabre-Kramer Pharmaceuticals, Inc in 2007)

It is also intended for those with non-clinical obesity who aim to improve overall health and reduce the risk of developing clinical obesity or other non-communicable diseases