Ami Fadia - Leerink Partners LLC
Analyst
Hi, good morning. Thanks for the question. I had two questions. Firstly, just a clarification on fremanezumab. You indicated that patients will have the option to either self-inject or have the dose injected at a healthcare professional's office. Now, how would that impact how the drug is reimbursed between the prescription benefit versus something like a buy-and-bill? And secondly, just with respect to Celltrion, could you give us a little bit more color around what gives you confidence that they will be able to address FDA's questions around the warning letter in the coming months, thereby triggering another FDA inspection? Or are you really telling us that irrespective of whether or not they address their issues, based on your conversations with the FDA, you still think that they'll come back for a re-inspection for fremanezumab? Thank you very much.
Kåre Schultz - Teva Pharmaceutical Industries Ltd.: Thank you very much, Ami. I'll try to explain how we see the Celltrion issue first, and then Brendan will talk about the thing about the injections and the reimbursement. So, the way we see it with Celltrion is, of course, they need to be in a good state of GMP, and we believe that they are and they have remedied the outstanding issues. But that's of course up to the FDA re-inspection to assess that. And what needs to happen is they need to have a re-inspection and there needs to be a PAI, pre-approval inspection, of fremanezumab API manufacturing. Now, on the API manufacturing, of course, we've been following that closely for the last years since it's crucial for fremanezumab. The actual 483 that Celltrion had last year in June, I believe it was, was actually on their finished pharmaceutical manufacturing. And of course, they have done everything needed to remedy those deficiencies that they had and they have of course had to inform FDA on an ongoing basis of what they were doing like any other manufacturer would have to do it. And they have to report to the FDA that they have now completed their remediation plan as they are ready to take a re-inspection. So, they have of course done that, and that is why that we say that we expect that there will be a warning letter re-inspection and a pre-approval inspection in the coming months. And of course, then any approval and launch is then on the assumption that Celltrion has done a good job and they are in a good state of compliance and that FDA will find this when they do the re-inspection and they do the pre-approval inspection. And based on that, we're saying that we expect approval and launch before the end of this year. So, I hope that clarifies it. Now, Brendan, could you explain about self-injection and injection at a clinic and reimbursement and so on in the U.S?