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the program demonstrated a favorable safety profile but the Phase IIb obesity trial produced modest weight-loss effects (mean reduction in treated groups roughly 2.6 kg vs

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Inhaled salmeterol: maximum 200 micrograms over 24 hours in divided doses not to exceed 100 micrograms over 8 hours starting from any dose Inhaled vilanterol: maximum 25 micrograms over 24 hours NOTE The presence in urine of salbutamol in excess of 1000 ng/mL or formoterol in excess of 40 ng/mL is not consistent with therapeutic use of the substance and will be considered as an Adverse Analytical Finding (AAF) unless the Athlete proves, through a controlled pharmacokinetic study, that the abnormal result was the consequence of a therapeutic dose (by inhalation) up to the maximum dose indicated above

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