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Suggested dosage can be repeated at 1 to 2 week intervals as indicated by the condition

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Trials conducted between 2001 and 2007 demonstrated statistically significant reductions in body fat, although the larger Phase IIb OPTIONS trial did not replicate these findings at sufficient magnitude for regulatory approval, and formal development was discontinued in 2007

For purposes of this paragraph (d), an extraordinary circumstance is an event beyond the control of an ASC (for example, a natural or man-made disaster such as a hurricane, tornado, earthquake, terrorist attack, or bombing) that affected the ability of the ASC to comply with one or more applicable reporting requirements with respect to a calendar year