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To comply, the study procedures included a negative pregnancy test before vaccination for all women of childbearing potential (ie, postmenarcheal and/or married women).
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Offspring were excluded if they were unable to comprehend or comply with the study protocol.
They also had to be willing to comply with the study procedures.
Patients and parents who were willing to comply with the study procedures were included.
All participants provided written informed consent and agreed to comply with the study protocol.
Among these, 14 owners were not willing to comply with the study protocol requirements.
○ Able, in the investigator's opinion, and willing to comply with the study requirements and follow-up.
Participants were healthy adults aged 18 to 60 years who the investigator believed would comply with the study requirements.
There were no specific exclusion criteria, other than inability to understand and comply with the study protocol.
All participants complied with the study until closure, resulting in zero dropouts.
181 subjects complied with the study protocol, 94 were randomised to receive L. reuteri and 87 received placebo.
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