Inclusion Criteria:

- Patient was previously enrolled in Study IMM 101 001

- Patient gives consent to make their disease and treatment history for the intervening
period between their completion of Study IMM-101-001 and enrollment in this study
available to the Sponsor

- Patient gives signed informed consent for participation in the study

Exclusion Criteria:

- Female patient of child-bearing potential who is not, in the opinion of the
Investigator, using an approved method of birth control (e.g., physical barrier
[patient and partner], contraceptive pill or patch, spermicide and barrier, or
intrauterine device [IUD]).

Those patients that utilise hormonal contraceptives must have used the same method for at
least three months before additional barrier contraception (as described above) is
discontinued from being used concomitantly with the hormonal contraception.

- Patient of non-child-bearing potential are defined as having 12 month amenorrhoea or
are surgically sterile.

- Female patient who is pregnant, breast feeding or planning a pregnancy during the
course of the study. A pre-treatment urine pregnancy test measuring human chorionic
gonadotrophin (hCG) must be negative.

- Patient is unable or unwilling to comply with the protocol.