[Changes to the protocol made until the stage of the statistical analysis plan, before data analysis and also before unblinding.]
1. Objective
1.1 Main Objective
We aim to determine, through mean INR difference between formulations, whether there is therapeutic equivalency between the branded
Background:
IBS (Irritable Bowel Syndrome) is a disorder of motility of the entire GI tract that produces cramping, abdominal pain, constipation, and/or diarrhea and sometimes passing of mucus in bowel movements. In most people with IBS, the GI tract is highly sensitive to many stimuli, including
Functional bowl disorders are defined as variable combinations of gastrointestinal symptoms that are not readily explained by structural or biochemical abnormalities. In children, these typically encompass irritable bowel syndrome and recurrent abdominal pain of childhood, two closely related
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