A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV

Inclusion Criteria: 1. Male or female participants ages ≥ 18 to 75 years. 2. Participants that have completed study protocol #101/2 3. A written informed consent signed prior to any study procedure being performed 4. Medically capable to undergo study procedures at the time of study entry Exclusion Criteria: 1. Participants that did not participate or did not complete 28 treatment days of study protocol #101/2. 2. Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication 3. Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant. 4. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2) 5. Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial