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At the first visit (11 + 0 to 13 + 6 weeks' gestation), eligibility will be confirmed, informed consent signed and these data entered into the database.
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If eligibility is confirmed, informed consent will be asked.
At the initial pre-operative appointment eligibility was confirmed, informed written consent was obtained and a questionnaire was given to participants to return by post before their operation.
During a subsequent call, the project was explained and patients were screened, and eligible patients were invited to a meeting where eligibility requirements were confirmed, informed consent was obtained, and a 1.5-h baseline assessment was completed.
At the meeting, eligibility requirements were confirmed, informed consent was obtained, and a 1.5-h baseline assessment was completed (A0) that included height and weight, questionnaires, brief interview, and visit to a community laboratory for collection of biological data.
At the initial study visit, eligibility criteria will be confirmed and informed consent obtained.
During the study visit patient eligibility was confirmed and informed consent was obtained.
After eligibility has been confirmed and informed consent has been obtained, urine is collected in a sterile container.
After eligibility criteria are confirmed and informed consent obtained, eligible patients are registered and the planned treatment is initiated by investigators.
When the eligible patients are confirmed and informed consent is obtained, the researchers login through the trial randomisation system and input the patient's number and other related information.
It will take several days before the first results of the karyotyping can confirm a clinical suspicion of DS. > The parents or caretakers of a child for whom a diagnosis of DS is being considered or has been confirmed should be informed in a supportive, positive, caring and honest manner [ 26].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com