A patient should only be randomized if ALL of the following conditions obtain:

(1) the patient meets all eligibility requirements,
(2) the tear size, as seen on MRI, is greater than 0 and less than or equal to 4cm (as determined by the treating physician),
(3) the patient has provided informed consent and confirmed willingness to participate,
(4) the Baseline Questionnaire has been completed, and
(5) the Physical Exam Form (CRF-02) has been completed.

IMPORTANT: Patients with pending MRIs who have been provisionally enrolled in the study, pending the results of their MRI, should not be randomized until their MRI results are known and they have been confirmed to meet ALL eligibility criteria. Likewise, patients provisionally enrolled in the study who needed more time to decide and unable to return for a research enrollment visit, should not be randomized until their willingness to participate in the study has been confirmed.