Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).
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 or the Prospectus, or the results of which are referred to in the Registration Statement 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 EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement 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 Registration Statement or 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 or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, 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 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.
Target Population TREATMENT FOR ADULT (TRA) Target Population
Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;
Screening The Health Plan must work with contracted providers to conduct interperiodic EPSDT screens on RIte Care and all ACA Adult Expansion Population members under age 21 (i.e. 19 and 20-year old under this Agreement) to identify health and developmental problems in conformance with ATTACHMENT ED to this Agreement. Additional screens should be provided as Medically Necessary. At a minimum, these screens must include: • A comprehensive health and developmental history, including health education, nutrition assessment, immunization history, and developmental assessment • Immunizations according to the Rhode Island EPSDT Periodicity Schedule • An unclothed physical examination • Laboratory tests including lead, TB, and newborn screenings as medically indicated • Vision testing • Hearing testing • Dental screening oral examination by PCP as part of a comprehensive examination required before age one (1) • All other medically indicated screening services • And provide EOHHS with a list of established CPT/HCPC codes used to identify all billable services included in the EPSDT schedule.