2.4.2. Exclusion Criteria
obesity, epilepsy, autoimmune diseases, Crohn’s disease, cholelithiasis, hemopathies, depressive disorder, endocrinopathies, drug abuse, panic disorder, bipolar disorder, post-traumatic stress disorder, schizophrenia, obsessive–compulsive disorder, bronchopneumopathies, bulimia, alcoholism, skin basalioma, weight loss, dermopathies, motor disability, biliary colic
OBESITY, ALLERGY TO SHELLFISH, INFLAMMATORY BOWEL DISEASE, EPILEPSY, NEOPLASMS, AUTOIMMUNE DISEASES, CHOLELITHIASIS, ENDOCRINOPATHIES, LIVER DISEASES, HEART, SUBCLINICAL HYPOTHYROIDISM, DYSLIPIDEMIA, ULCERATIVE COLITIS, CELIAC DISEASE, NEPHROPATHIES, GENETIC SYNDROMES, EVENT, CHRONIC DISEASES, SECONDARY, PEPTIC ULCERS, BILIARY COLIC, CARDIOPATHIES, AUTOIMMUNE THYROIDITIS
Allergy to shellfish or any ingredient in the product; women with presumed or confirmed pregnancy, or in feeding time; subjects with clinically significant cardiopathies, nephropathies, liver diseases, bronchopneumopathies, hemopathies, dermopathies, or chronic degenerative diseases of the central nervous system; subjects with active peptic ulcers, ulcerative colitis, Crohn’s disease, celiac disease, or inflammatory bowel disease; subjects with symptomatic cholelithiasis (at least one episode of biliary colic in the last 6 months) or autoimmune diseases (except autoimmune thyroiditis); subjects with previous or current neoplasms (except skin basalioma diagnosed more than five years previously); subjects with epilepsy (current or previous); obesity secondary to endocrinopathies, or obesity associated with genetic syndromes or other endocrinopathies (except subclinical hypothyroidism with normal TSH values); subjects with significant motor disability or mental retardation; subjects with confirmed or suspected diagnosis of major depressive disorder, bulimia, panic disorder, obsessive–compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), or schizophrenia; a previous history or current diagnosis of drug abuse or alcoholism; subjects with changes in smoking habits or that have quit smoking in the last 6 months; subjects that currently use psychoactive drugs, or that have used psychoactive drugs in the last 3 months, or that currently use drugs for chronic diseases affecting body weight or appetite (including: antiobesity drugs), or that have used these drugs in the last 12 months; previous diet therapy attempts, with at least 5% weight loss in the last year and a fluctuation of at least 3 kg in the previous 3 months; subjects with a risk of a cardiovascular event equal to or greater than 20% during the previous 10 years, according to the tables of the Istituto Superiore di Sanità—Heart project; subjects taking medication for dyslipidemia; subjects with TSH levels below or exceeding the normal range, an AST or ALT exceeding 2.5 times the upper limit of normal, or hemoglobin < 11 g/dL, neutrophils > 1500/mm