2. Administration of immunoglobulins or any blood product during the study period If any of the above occurs that might compromise per protocol assessment (PP); however, they will not be withdrawn from the study and their data will be used in an "intention to treat" (ITT) analysis. The investigator(s) might also withdraw a participant if, in his/her clinical opinion, that is in the best interest of the participant concerned or if it is considered to be non-compliant with the protocol. A participant might also be withdrawn due to protocol violation, death or early termination of the study by the sponsor. Wherever possible, the tests and evaluations at termination visit, as specified in the protocol, will be carried out.