To the long version

We sent our criticism to all authors of the study. The lead author responded, but not in the way we expected.  On June 16, 2021, a new version of the study protocol, allegedly created on February 6, 2014, was uploaded to the www.clinicaltrials.gov registry.

In summary:

July 31, 2019: Termination of the study

September 18, 2019: Upload of a study protocol, allegedly created on January 10, 2011, which demonstrably contains content from a later date than the stated creation date, namely from the published paper. At the time of the upload, the authors are aware of the results.

June 6, 2021 We send our criticism to all authors of the study.

June 14, 2021 Upload of a new study protocol, allegedly created on February 6, 2014,  - this now contains all data as in the published study. 

• To date, there is no explanation for the massive changes to the study protocol parameters during or after completion of the study. 

• To date, there is no explanation for the missing excluded patients in the Consort diagram, even though a myriad of exclusion criteria were introduced. 

• It remains unclear why a study protocol, allegedly created in 2011, was uploaded in 2019, even though the newer protocol, allegedly created in 2014, already existed at that time. 

• To date (10 November 2022), there has been no response from the authors contacted more than a year ago. 

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