Sentences with phrase «regarding subsequent activities»

Educated patients and their support person regarding subsequent activities and expectations toward optimal readiness in progression to delivery.

Not exact matches

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Regarding the child, the importance of the intrauterine and early postnatal environments for metabolic programming and modifications of the epigenome is increasingly recognised, 12 — 14 particularly for metabolic diseases such as obesity and diabetes.15 Thus, GDM is related to macrosomia at birth (> 4 kg), to excess body fat and (central) obesity and to insulin secretion in infants and children, the obesity being in part mediated by maternal body mass index (BMI) or birth weight.16 — 23 Intrauterine exposure to GDM also doubles the risk for subsequent type 2 diabetes in offspring compared with offspring of mothers with a high genetic predisposition for type 2 diabetes, but with normal glucose tolerance during the index pregnancy.24 Maternal prepregnancy overweight and excessive gestational weight gain also predict high birth weight and adiposity during infancy.12 25 This is highly relevant, as up to 60 % — 70 % of women with GDM are overweight or obese before pregnancy.26 Finally, maternal lifestyle behaviour such as a high fat diet or lack of physical activity during pregnancy can influence offspring adiposity independent of maternal obesity.12 27