The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.

Inclusion criteria:

• Patient randomized, treated and alive at the end of the phase I-II study participation, irrespective of their treatment group,
• Who signed the TALISMAN survey informed consent (or for deceased patients, the informed consent was signed the legal representative/family member as per national regulations - except in countries where Ethics Committee approval only is required for retrospective data collection).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Patients participating in this observational study previously participated in one of the phase I-II studies for the compound