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Article History

Received: 12 June 2018

Accepted: 28 November 2018

First Online: 12 December 2018

Ethics approval and consent to participate

: We carried out the follow-up study according to the ethical principles originated from the Declaration of Helsinki, guidelines of good clinical practice, and applicable regulatory requirement. The follow-up study was also approved by the Committee for Medical Ethics of the hospital network in Antwerp, Belgium (Ziekenhuis Netwerk Antwerpen) (EudraCT No.:B009201627877). Informed written consent was signed by the subject’s legally acceptable representative.

: Written informed consents for publication were also obtained from all of the participants for the follow-up study.

: The authors are employed by Yakult Honsha European Research Center for Microbiology ESV (East Flanders, Belgium) or Yakult Central Institute (Tokyo, Japan), which are institutions affiliated with Yakult Honsha Co., Ltd. (Tokyo, Japan). There are no patents, products in development, or marketed products to declare. This does not alter our adherence to all of BioMed Central’s policies on sharing data and materials.

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