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Article History

Received: 22 May 2018

Accepted: 31 October 2018

First Online: 16 November 2018

Ethics approval and consent to participate

: This retrospective, observational study was carried out in real-life setting, with approved drugs. Patients were not exposed to any experimental interventions nor did the study intervene with the clinical management of the patient. The study only collected information from patient records. The analysis included routine examinations and tests performed in patients treated within the therapeutic program of the National Health Fund. The data was originally collected to assess treatment efficacy and safety in individual patient, not for scientific purposes. Hence, the treating physicians did not take approval from the ethics committee of any research/academic institute. According to local law (Pharmaceutical Law of 6th September 2001, art. 37al) non-interventional studies do not require approval of ethics committee. Patients signed informed consent for treatment and processing of personal data. Patients’ data were collected through an on-line system and only physicians who have patients in care had access to patients’ personal information.

: The manuscript doesn’t contain details, images, or videos relating to an individual person.

: EJ has received research grants and/or fees for lectures, advisory boards, scientific consultancies from Abbvie, Allergan, Bristol Meyer Squibb, Gilead Sciences, Janssen Cilag, MSD, Vertex, Tobira. AP has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, Gilead, Merck, Roche. WM has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, BMS, Gilead, Janssen, Merck, Roche. TBM has received research grants and fees for scientific consultancies for: AbbVie, Gilead. WD has received fees for scientific consultancies from: AbbVie, Gilead. ACA has received research grants from: AbbVie, Merck. JJ has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, BMS, Gilead, Merz, Roche. ŁS has received fees for scientific consultancies from BMS. BA has received research grants from BMS and fees for scientific consultancies from Roche, AbbVie, BMS, Gilead, MSD. WH has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, BMS, Gilead, Janssen, Merck, Roche. BBC has received research grants and/or fees for lectures, scientific consultancies from: AbbVie, Gilead, Roche. KT has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, Alfa Wasserman, BMS, Gilead, Janssen, Merck, Roche. KS has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, Gilead, BMS, Merck, Janssen, Alfa-Wassermann, Baxter, Bayer, Roche Allergan, EISAI, Gilead, Intercept, Tobira, Pfizer.AG has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen, Roche, Sanofi Pasteur, Amgen, Pfizer. MWS has received fees for lectures, scientific consultancies from: Gilead, AbbVie, Merck. RF has received research grants and/or fees for lectures, advisory boards, scientific consultancies from: AbbVie, Alfa Wasserman, BMS, Gilead, Janssen, Merck, Roche, Shionogi. DZM, HB, DD, MTZ, ZD, IB, MS, BL, JBW, JC, ŁL, OT, AH, AG declare no competing interest.

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