Kachko, Vera A. http://orcid.org/0000-0002-0617-7312
Shulman, Lee P. http://orcid.org/0000-0002-4781-0866
Kuznetsova, Irina V. http://orcid.org/0000-0001-5541-3767
Uspenskaya, Yulia B. http://orcid.org/0000-0002-5714-3462
Burchakov, Denis I. http://orcid.org/0000-0001-9081-9041
Clinical trials referenced in this document:
Documents that mention this clinical trial
Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen® and Smart B® in Women with Climacteric Syndrome in Perimenopause
https://doi.org/10.1007/s12325-024-02910-0
Article History
Received: 14 February 2024
Accepted: 22 May 2024
First Online: 21 June 2024
Declarations
:
: Vera A. Kachko is a scientific advisor in Alliance Pharmaceuticals Ltd., Lee P. Shulman is a consultant for Alliance Pharmaceuticals Ltd. Lee P. Shulman is an Editorial Board member of<i> Advances in Therapy</i>. Lee Shulman was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Irina V. Kuznetsova was the main investigator of this trial, Yulia B. Uspenskaya and Denis I. Burchakov were investigators in this trial.
: The trial was conducted according to the principles of the World Medical Association Declaration of Helsinki “Recommendations guiding physicians in biomedical research involving human subjects” (accepted in 1964, last updated in 2000, with explanations added in 2002, 2004, 2010, and 2013) and the National Standard of the Russian Federation “Clinical practice” (52379–2005, 27.09.2005, No 232-SP). Protocol of the trial, independent review committee (IRC), informed consent form, and other documents were presented and approved by the Ethics Committee of I.M. Sechenov Moscow State Medical University for independent expert analysis (Protocol excerpt No. 04-19, Local Ethics Committee session March 6, 2019). Informed consent forms signed and dated by study subjects indicate their agreement to participate in the study.