Menarini Group Sponsor: A. Menarini Industrie Farmaceutiche Riunite S.r.l. Amended Protocol Version 4.0 of 16.04.2018 Study Code : MEIF/16/MOF -Col/001 CLINICAL STUDY PROTOCOL Title: A randomized, double-blinded, placebo-controlled, clinical study of the effects of a nutraceutical combination on LDL cholesterol levels in subjects with sub-optimal blood cholesterol levels. (Acronym: NATCOL) Study code: MEIF/16/MOF-Col/001 Study type and design: A clinical, exploratory, monocentric, interventional, non-drug, randomized, placebo-controlled, double-blinded, parallel-group study. Amended Protocol version n°: 4.0 Release Date: 16.04.2018 Principal Investigator: Prof. Claudio Borghi Ambulatorio Dislipidemie e Aterosclerosi/Ambulatorio per la Diagnosi e Cura dell’Ipertensione Dipartimento di Scienze Mediche e Chirurgiche, Alma Mater Studiorum Università di Bologna Phone: +39.051.2142843 - Fax: +39.051.391320 CRO: OPIS s.r.l. Via Matteotti 10, 20832 Desio (MB), Italy Phone: + 39 0362 6331 - Fax: +39.0362.633633 E-mail:
[email protected] Sponsor: A. Menarini Industrie Farmaceutiche Riunite S.r.l. Offices: Via dei Sette Santi 3, 50131 Firenze Phone: +39.055.5680.1 – Fax: +39.055.58.27.71 CONFIDENTIALITY STATEMENT The information in this document contains trade secrets and commercial information that are privileged or confidential and may not be disclosed unless such disclosure is required by law. In any event, persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or confidential .