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Article History

Received: 18 June 2018

Accepted: 11 April 2019

First Online: 30 April 2019

Ethics approval and consent to participate

: In Spain, only the clinical trials with medicines are regulated by Royal Decree 1090/2015, of December 4, and Regulation (EU) No. 536/2014, without there being regulations that regulate the trials of intervention in humans with food.The Spanish Agency for Food Safety (AECOSAN), under the Ministry of Health and Consumption, is the Spanish entity that regulates food supplements and does not establish administrative procedures prior to conducting an intervention trial in humans with food.Therefore, no approval of the ethics committee is needed since Libicare® is a food supplement.However, the pilot study that has been presented has been carried out following a well-defined protocol, and in accordance with the main premises of Good Clinical Practices and the Declaration of Helsinki.In this way, all the participants have been informed, before their inclusion, of the possible risks and benefits, and of all the aspects of the study and have signed an Informed Consent expressing their willingness to participate. Likewise, during the study, all adverse events were registered and followed, fulfilling the maximum premise of safeguarding the safety of patients.

: Not applicable.

: Dr. Santiago Palacios. Honoraria or consultation fees and participation in a company sponsored speakeaker’s bureau: Bayer Healthcare, Bioiberica, Ferrer, Exeltis, Gedeon Richter, Gynea, MSD, Novo Nordisk, Pfizer, Procare Health Iberia S.L., Serelys, Servier, Shionogi, Teva. He also is a member of the editorial board of BMC Women’s Health journal.Dr. Fernando Losa. Consultant in Spain Bayer, Procare Health Iberia S.L., E-Care You.Mrs. Eva M. Soler, Dr. Marieta Ramirez and Dr. Mariella Lilue declare no competing interests. Danial Khorsandi Ph.D. Principal researcher of the Procare Health Iberia S.L. and he has financial ties with Procare Health Iberia S.L.

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