Discussion of Study Design Sample Clauses

Discussion of Study Design. This is an open-label study to provide safety data in patients with advanced stage DMD. The study focuses on safety assessments; however, because a majority of patients with advanced stage DMD are non-ambulatory, CCI The 96-week duration of the study provides sufficient follow-up time to obtain safety data in this population. The safety extension (not to exceed 48 weeks) will allow patients who have been receiving once weekly infusions of eteplirsen in Study 4658-204 to continue treatment until the product is commercially available or they are able to transition to another eteplirsen study.
Sample 1
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Discussion of Study Design. Including the Choice of Control Groups 5 SELECTION OF STUDY POPULATION 5.1 Inclusion Criteria (1) Signed informed consent from one of the parent(s)/legal representative(s). (2) Subjects, both genders, aged 3 to 60 months. (3) Subjects with acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than 3 days). 5.2 Exclusion Criteria (1) Known allergy to Racecadotril or any of its ingredients. (2) Subjects suffering from renal or hepatic impairment. (3) Subjects with fever > 39 degrees Celsius (4) Subjects with bloody and/or purulent stools. (5) Subjects suffering from antibiotic (e.g. amoxicillin)-associated diarrhea, chronic diarrhea or iatrogenic diarrhea. (6) Subjects with alternating bouts of diarrhea and constipation. (7) Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, irritable bowel disease or pancreatic exocrine insufficiency. (8) Cystic fibrosis or coeliac disease. (9) Subjects suffering from prolonged or uncontrolled vomiting. (10) Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency. (11) Subjects having received antibiotic treatment within 2 weeks prior to start of the current diarrhea episode. (12) Subjects having received antidiarrheal drugs (except pre- or probiotics see section 7.7.) 48 hours prior to Day 1. (13) Subjects with severe dehydration requiring intravenous fluid or electrolyte replacement or hospitalization treatment. (14) Subject with a history of angioedema or who had reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) (15) Subjects with combined diseases or medical situations that would prevent to be enrolled into the study, depending on the judgment of the investigator (16) Intake of experimental drug within 30 days prior to study start. (17) Subjects with contraindications to ORS or susceptible to the warnings of ORS.
Sample 1

Related to Discussion of Study Design

  • Study Design This includes a discussion of the evaluation design employed including research questions and hypotheses; type of study design; impacted populations and stakeholders; data sources; and data collection; analysis techniques, including controls or adjustments for differences in comparison groups, controls for other interventions in the State and any sensitivity analyses, and limitations of the study.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

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