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The application contained data from the Phase III FOCUS study, a single-arm, open-label trial which enrolled 91 patients who were treated every six to eight weeks for up to a maximum of six cycles

Injectables require refrigeration, which may be challenging for patients without stable housing, privacy, or climate control

Another placebo-controlled, double-blind, randomized study in 44 men with idiopathic asthenozoospermia found an increase in sperm motility in those given ALCAR alone (3 g/day) or ALCAR (1 g/day) plus L-carnitine (2 g/day) compared to those given L-carnitine alone (2 g/day) or a placebo (113)

Diagnostic imaging and testing , including endoscopy reports, gastric-emptying studies, and lab data showing nutritional deficits or electrolyte abnormalities

Luk, E., Carroll, M., Baker, M