Document is current

Article History

Received: 24 February 2021

Accepted: 27 February 2021

First Online: 2 April 2021

Declarations

:

: The protocols, informed consent forms, and all patient materials were submitted for institutional review board review and approval and were approved before any patient was enrolled. K031 protocol version 3 (dated 14 Jul 2020) and informed consent form received IRB approval on July 21, 2020 by Advarra (Protocol #Pro00043557). K031 protocol version 4 (dated 09 Dec 2020) received IRB approval on December 10, 2020 by Advarra (Protocol #Pro00043557). K032 protocol version 1 (dated 02 June 2020), memo (dated June 4, 2020), and informed consent received IRB approval on July 2, 2020 by Advarra IRB (Protocol #Pro00044842). K032 detailed protocol version 2 (dated 06/30/2020), protocol summary (dated 07/09/2020), protocol schema, investigator’s brochure information (dated 4/29/2020), Kaleido Biosciences: K032-120CRO: Medpace Device Brochure, summary of changes for K032-120 version 2 (dated 30 June 2020), summary of changes for K032-120 version 1 (dated 02 June 2020), questionnaires (3), instruments/study tools (2), recruitment brochures (3), contact letters (2), informed consent (1), advertisements (1), and flyers (1) received IRB approval on June 23, 2020 by Partners Human Research PHS IRB (Protocol #2020P001324). The authors ensure these studies are conducted in full conformity with Regulations for the Protection of Human Patients of Research codified in 45 CFR Part 46, 21 CFR Parts 50 and 56, and /or the principles in the International Council for Harmonization E6 (R2) Good Clinical Practice guideline.Prior to inclusion, potential patients will first receive written and verbal information from the Primary Investigator (PI), or designee on purpose of the study and of the clinical procedures required by the protocol. Patients will have the opportunity to carefully review the consent form and ask questions prior to completing. Informed consent to participate in the study will be obtained from all participants. The informed consent form will be retained in the patient’s records and a copy of the informed consent form will be provided to the patient.

: Not applicable

: JPH: No competing interests JCP: No competing interestsNAP, YZ, MW: Employed by and hold stock in Kaleido Bioscience, Inc