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Table 2 Protocol versions

From: Safety, effectiveness, and economic evaluation of an herbal medicine, Ukgansangajinpibanha granule, in children with autism spectrum disorder: a study protocol for a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group clinical trial

Version

Date

Action

1.0

2017-Jul-06

Protocol draft development

1.1

2017-Jul-13

Statistical review

1.2

2017-Aug-02

Ethical issue review

1.3

2017-Aug-04

Deleting EHWA-Checklist for Autistic Children as an outcome measure

1.7

2017-Dec-06

Revision following institutional review board’s comments

2.0

2018-Jan-10

Revision of inclusion criteria and Aberrant Behavior Checklist

2.1

2018-Mar-13

Amendment of Investigational New Drug review

2.2

2018-Mar-22

Additional amendment

2.3

2018-Jun-01

Minor amendment including typing errors