Depositions

Video Content:



 

This clip shows the result of USC evaluation of the Sargon Implant system.

4 Q. Do you recall what you said about the

5 Sargon dental implant to the FDA?

6 A. I can make a general --

7 Q. Okay.

8 A. I had a very positive opinion about the

9 system.

10 Q. Has your opinion changed since then?

11 A. I don't think so.

12 MR. BLOOM: I'm going to show you a document

13 which I'll have marked as Plaintiff's 19.

14 (Deposition Exhibit No. 19 was marked for

15 identification and is annexed hereto.)

16 BY MR. BLOOM:

17 Q. Do you recognize this document, sir?

18 A. Yes, I do.

19 Q. What is it?

20 A. An evaluation.

21 Q. You prepared it?

22 A. Yes, I did.

23 Q. On or about November 4, 1997?

24 A. I think so.

25 Q. You submitted that to the FDA?

545

1 A. Yes, and an oral presentation.

2 Q. Excuse me?

3 A. And an oral presentation.

4 Q. You made an oral presentation and you

5 also gave this report?

6 A. Yes.

7 Q. So you made an oral presentation and you

8 also submitted this document to them?

9 A. Yes.

10 Q. Looking at the last paragraph, it

11 says -- in fact, you know what, I'll just let you

12 read it silently.

13 A. Yes.

14 Q. Was that true when you made it? The

15 statements you made, were those true when you said

16 them or when you wrote this?

17 A. Yes.

18 Q. Do you still agree with them now?

19 A. Yes.

This clip shows the reasons for stopping the use of the Sargon implant system at USC were personal.

21 Q. But at the time that you gave this
22 presentation to the FDA, you said in this report
23 anyway that, "Our results indicate that the Sargon
24 tooth replacement system seems to be the most
25 advanced treatment modality available at the present
548
1 time." That was true when you made that statement,
2 correct?
3 A. That is a true statement.
4 Q. It is also true now, isn't it?
5 A. Now, it is a different situation. My
6 problem is not with the implant. My problem is with
7 the person. That is why when you are asking me the
8 question whether or not I would try to use the system
9 in the hope of getting the same kind of result, I
10 would tell you "no."
11 Q. Why "no"?
12 A. Because of the person.
13 Q. You mean Dr. Lazarof or the patient?
14 A. Dr. Lazarof.
15 Q. Do you mean to say that you would stand
16 by this statement being true today if Dr. Lazarof was
17 no longer around for whatever reason?
18 A. No, that is not what I said. I said the
19 reason. You said that if I was using the system
20 today.
21 Q. I'm sorry, I didn't understand.
22 A. Then I misunderstood. I'm sorry.
23 Q. I simply asked the following. In
24 November of 1997, you gave a presentation to the FDA
25 and also submitted this report, which states that,
549
1 "The Sargon tooth replacement system seems to be the
2 most advanced treatment modality available at the
3 present time." That was a true statement when you
4 made it, correct?
5 A. That was a true statement.
6 Q. Is it still a true statement?
7 A. I believe so.

This clip shows Nowzari's involvement with the Sargon histological studies conducted in Rennes France. Even though the studies had positive results, Nowzari is refusing to publish them.

4 Q. Whose idea was it to have this study
5 conducted at the University of Rennes?
6 A. I believe it was a collective decision
7 between me and Dr. Michel.
8 Q. That is Jean-Francois Michel?
9 A. Yes.
10 Q. Then did you bring this to Dr. Lazarof's
11 attention, the idea of doing this study?
12 A. Yes.
13 Q. What did he say about it?
14 A. He seemed to be grateful about that
15 because I believe that they were studying or they
16 were going to study the Branemark implant, so we
17 could use this implant as a controlled test.
18 Q. Did Dr. Lazarof or someone at Sargon
19 Enterprises pay for this study?
20 A. He provided materials. By "materials,"
21 I mean --
22 Q. The implants?
23 A. You know what, there is a contract
24 between the University of Rennes and mine. It is
25 very much in detail. Everything is clear in that
553
1 if you would read it.
2 Q. You signed that contract?
3 A. That contract was signed by -- if I
4 remember well, by the president of the University of
5 Rennes and Guy Cathelineau and Jean-Francois Michel
6 and myself.
7 Q. When did that study begin, do you know?
8 A. I don't remember.
9 Q. Did you make an oral presentation of the
10 results of that study at the Monte Carlo Symposium?
11 A. No.
12 Q. Do you know if anybody else reported the
13 findings of that study at the Monte Carlo Symposium?
14 A. Jean-Francois Michel did.
15 Q. Were you present when he made that
16 presentation?
17 A. I believe so. I'm not sure if I was
18 present for the entire presentation. Probably I was.
19 Q. For whatever period of time you were
20 there during his presentation, did he provide
21 truthful and accurate information concerning that
22 study?
23 A. Yes, he did.
24 Q. Was it a positive study?
25 A. Studies are always positive.
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1 Q. I mean positive in that the results were
2 favorable to the implant; is that true?
3 A. I don't like the word "favorable," but I
4 will answer your question.
5 Q. Okay.
6 A. You could say so.
7 Q. Was there something that was not
8 favorable?
9 A. Even if, let's say, that the implant,
10 they would fail. I would still consider it as
11 favorable because it gives you an opportunity to
12 correct the problems. Studies are always positive.
13 Q. Just the fact that you do a study is a
14 positive?
15 A. Yes. Again, I'm a teacher. I look at
16 it from a different angle, but I understood your
17 question, whether or not the implant, this implant,
18 had -- like many people, they were speculating that
19 by expanding the implant, you may get bone research,
20 and that was not the case.
21 Q. So the findings from the study were
22 favorable to the efficiency or efficacy of the
23 implant; is that true?
24 A. No.
25 MR. THOMPSON: Objection. Vague and ambiguous.

555

1 Incomplete hypothetical.

2 BY MR. BLOOM:

3 Q. Were there any unfavorable findings?

4 A. You know, the finding of the study was

5 that both implant systems, they were providing good

6 osseous healing.

7 Q. "Both," meaning it was the Sargon

8 implant system and also the Branemark?

9 A. That is right.

10 Q. What kind of Branemark implant was being

11 used in that study?

12 A. I don't remember, but they are all

13 commercially pure titanium.

14 Q. Was it a Branemark implant which was

15 suitable for immediate loading?

16 A. I really don't know what is suitable for

17 immediate loading.

18 Q. Were the results of that study ever

19 published?

20 A. No.

21 Q. Why not?

22 A. Because we wanted to make sections, I

23 don't remember, of 10 or 60 microns, and there was no

24 saw available. It was very difficult. The price of

25 the saw only was at the time I think 100,000 francs.

556

1 Q. The price of the what?

1 Q. The price of the what?
2 A. The saw to cut the implant and the bone.
3 It was very expensive, very difficult. It is a
4 difficult procedure. It is relatively new
5 technology. I think you have to purchase it or get
6 it from Germany. That one postponed the study a
7 little bit. I don't remember. Maybe one of the
8 animals had to be replaced. Otherwise, the active
9 part of the study is finished.
10 Q. I don't understand exactly why the
11 results were not published. Was it because there was
12 some delay in obtaining a saw and one of the animals
13 had to be replaced?
14 MR. THOMPSON: That is what he said.
15 BY MR. BLOOM:
16 Q. How did that affect whether or not the
17 study results would be published?
18 A. The study results probably is going to
19 be published.
20 Q. How come it hasn't been published today?
21 A. Because once you have all the results,
22 you have to put them together, do the analysis, write
23 the manuscript, send it to different people to check
24 the manuscript.
25 Q. When was the study completed?
557
1 A. Which part of the study?
2 Q. The entire study.
3 A. The entire study is not finished because
4 writing the manuscript is part of the study.
5 Q. How long of a study was it supposed to
6 be?
7 A. I think we were going to evaluate
8 histologically and doing electromicroscopy and some
9 other tests, I don't remember now, after 56 days,
10 after placement.
11 Q. 56 days?
12 A. This is the design of the study. So
13 please don't think that the study is going to be
14 finished after 56 days. We place the implants and we
15 check the healing at the time of placement maybe one
16 week later and then 20 days later, and then after,
17 56 days. Obviously, you need test and control, 18 positive control and negative control.

19 MR. BLOOM: Let me show you a document, Doctor,
20 that we will have marked as Plaintiff's 20. It 21 purports to be a letter addressed to Sargon signed by
22 Dr. Jean-Francois Michel and Dr. Guy Cathelineau.
23 (Deposition Exhibit No. 20 was marked for
24 identification and is annexed hereto.)
25 MR. HARMSEN: What is the date of the letter,

558
1 Barry?
2 MR. THOMPSON: It looks like it is the 21st of
3 December 1998. It is the reverse order, French style
4 of dating.
5 Go ahead and take your time to read
6 that.
7 THE WITNESS: Yes.
8 BY MR. BLOOM:
9 Q. Have you ever seen that letter before?
10 A. No.
11 Q. The reason I show it to you, Doctor, is
12 just because of a sentence which stated here that, "A
13 first paper is being written and corrected and will
14 be sent for publication during the first term of
15 1999." Do you see that?
16 A. Yes, I do.
17 Q. Was it your understanding, Doctor, that
18 a paper would be sent for publication during the
19 first term of 1999?
20 A. No, not necessarily.
21 Q. What was your understanding as to when a
22 first paper would be sent for publication, at what
23 time?
24 A. Whenever the manuscript is ready.
25 Q. What was your understanding when this
559
1 study was first commenced as to when a manuscript
2 would be submitted?
3 A. I didn't think about that on this
4 specific date.
5 Q. Are you performing any act, Doctor, to
6 prevent the publication of the results of that study?
7 A. No.
8 Q. Did you give Dr. Lazarof the slides of
9 the animals taken in connection with that study?
10 A. Yes.
11 Q. You gave him all the slides?
12 A. I didn't have to.
13 Q. How do you mean?
14 MR. THOMPSON: His question is, did you give
15 him all the slides?
16 THE WITNESS: No.
17 BY MR. BLOOM:
18 Q. Why didn't you have to?
19 A. Why I didn't have to?
20 Q. Yes.
21 A. Read the contract.
22 Q. Is there something in the contract that
23 states that you don't have to give him slides?
24 A. Nobody can do anything with the results
25 of that study without the permission of the president
560
1 of the University of Rennes and myself.
2 Q. But you gave him some slides?
3 A. I gave him some slides.
4 Q. But you didn't give him all the slides?
5 A. At the time, I gave him whatever I had.
6 Q. At the time you gave him slides, you
7 gave him all the slides you had?
8 A. I don't think that anybody had all the
9 slides. 10 Q. Where are all the slides?
11 A. All the slides are in Rennes.
12 Q. Have all those slides been provided to
13 Dr. Lazarof?
14 MR. THOMPSON: If you know.
15 THE WITNESS: I don't know.
16 BY MR. BLOOM:
17 Q. You gave him some slides?
18 A. I gave some slides.
19 Q. Where did you get the slides that you
20 gave to him?
21 A. I gave it to him, Dr. Landesman, and
22 then he asked me to give them to the administrative
23 assistant at USC, to mail it to him. He didn't want
24 to mail it directly himself.
25 Q. Who is "he"?
561
1 A. Dr. Landesman.
2 Q. I'm not sure I understand. You gave
3 some slides to Dr. Landesman?
4 A. I was not collaborating at the time with
5 Dr. Lazarof anymore, but I told Dr. Landesman that it
6 is not going to -- I can provide him the slides. I
7 gave them to Dr. Landesman and he told me, "No, you
8 send it yourself."
9 Q. Send it to Dr. Lazarof yourself?
10 A. "If you want it, you do it yourself."
11 Q. What did you do?
12 A. I think me and him decided to give it to
13 the assistant of the department. I don't remember
14 who exactly, and he or she mailed it to his office.
15 Q. To Dr. Lazarof's office?
16 A. Right.
17 Q. How did you select the slides to give to
18 Dr. Landesman?
19 A. I didn't select the slides. 20 Q. They were all the slides you had
in y
our 21 possession?
22 A. I believe I had more than two of each.
23 So it was simple.
24 Q. Who is going to write the manuscript for
25 that study?
562?
1 A. It is going to be collective work.?
2 Q. Are you going to be involved with that??
3 A. I have to be involved with that.?
4 Q. Have you started writing the manuscript?
5 for that study??
6 A. Last time -- actually, it was a few days?
7 ago that I started.?
8 Q. You did start it??
9 A. Yes.?
10 Q. Was it two separate studies then, one?
11 study on the Sargon dental implant and then another?
12 study for the Branemark dental implant??
13 A. No. This one is a controlled study, so?
14 we need positive control and negative control. That?
15 is why it was designed this way.?
16 Q. But there is only one study??
17 A. It is one study. ?
Nowzari denies writing Sargon Implant endorsement letters.
After the University was presented with expert report on patient record Alterations, Nowzari is trying to explain. 9 Q. Was there a custom and practice in
10 regard to the surgeries on the clinical trial
11 patients concerning who would write notations in
12 the chart concerning the surgery?
13 A. Not really.
14 Q. Did you think it was a good practice to
15 perform a clinical trial study without a custom and
16 practice as to who would make notations concerning
17 the surgery?
18 MR. THOMPSON: Did you ever think about that,
19 whether or not it was a good practice as described by
20 Mr. Bloom?
21 THE WITNESS: You know, in the charts, the
22 patient charts, obviously, you have to do your best,
23 but at the same time, it is a teaching institute.
24 Myself, I'm a member of Quality Assurance, and I can
25 tell you it is very difficult to find charts which
502
1 are filled absolutely completely because --
2 MR. THOMPSON: You've answered the question.
3 He will follow up if he wants to.
4 BY MR. BLOOM:
5 Q. Well, was there any custom and practice
6 concerning the type of information which would be
7 placed in the patient's chart with respect to the
8 surgeries?
9 A. I believe you write whatever you see we
10 do for surgical procedures, medication --
11 Q. Tell me the things that were customarily

12 placed in the chart concerning the surgeries. 13 A. When I write it --
14 Q. I'm going to have to interrupt you, 15 Doctor. Are you saying, before you even finish your
16 answer, that there was a different custom and
17 practice if you wrote it versus if someone else
18 wrote it?
19 A. It may be different.
20 Q. Do you believe it is appropriate to have
21 different items written in a chart for a surgical
22 procedure in the context of a clinical trial study?
23 MR. THOMPSON: Objection. Argumentative.
24 Misstates his prior testimony.
25 MR. KENNEDY: Assumes facts not in evidence.
503
1 THE WITNESS: The information that we were
2 going to use for the clinical trial, they would be
3 intact.
4 BY MR. BLOOM:
5 Q. Excuse me?
6 A. They would be available.
7 Q. It would be available how?
8 A. Both inside the medical chart or the
9 research chart, because these patients, they are
10 implant patients. The prosthetic residents do a very
11 comprehensive treatment planning and then writes a
12 letter that, to me, is a well-written letter. Then
13 they present it to us, to Dr. Chee, to myself, or
14 whoever, or maybe to the director of the
15 maxillofacial department. We will try to do
16 our best. I really don't understand your
17 questions.
18 Q. Well, my question, Doctor, is, in a
19 clinical trial, is it important to try to standardize
20 the procedures as much as possible?
21 MR. THOMPSON: Which procedures?
22 MR. BLOOM: Any procedures.
23 THE WITNESS: It is a good idea to standardize
24 as much as you can, knowing the limits at the same
25 time. It would be wonderful if you could finish the
504
1 surgery and write it immediately.
2 BY MR. BLOOM:
3 Q. Whether it is written immediately or
4 later, in connection with this clinical trial, was it
5 your intention to try in regard to each patient to
6 record the same categories of information regarding
7 the surgery so that upon a later review, we could see
8 that the same things were noted, the same categories
9 of things were noted, in regard to each surgery? Was
10 that your intention to do?
11 A. That is our intention.
12 Q. Was that done?
13 A. You know, now that I'm talking to you,
14 I've been a member of that Quality Assurance. Still
15 you are trying to find out --
16 MR. THOMPSON: Just answer his question. He is
17 saying, was that done in this case?
18 THE WITNESS: No.
19 BY MR. BLOOM:
20 Q. Why not?
21 A. Because, you know, our system is not
22 computerized. The charts are written by hand. We
23 have lots of people involved with one patient. When
24 you go immediately after surgery, you have to take a
25 radiograph, and the radiology department requests the
505
1 chart. So the chart cannot be with them and then
2 with you. Then the patient has to go to the
3 prosthetics department to have a provisional made,
4 and they have to have the chart. So who is going to
5 write first? 6 If the radiology department is going to
7 write first, I don't have any problem with that
8 personally because we all have good intentions.
9 Chronologically, the surgeon has to write it first
10 and then the radiology department maybe is second and
11 then the prosthetics department is third. So was it
12 a standard? As I agree with you, it was not, but
13 what else could we do? Hopefully --
14 MR. THOMPSON: You've answered his question.
15 BY MR. BLOOM:
16 Q. Doctor, I assume that in any
17 hypothetical implant surgery, there is certain
18 information that the surgeon desires to put in the
19 chart; is that accurate?
20 A. Yes.
21 Q. What type of information does a surgeon
22 such as yourself customarily want to put in a chart
23 in connection with the surgical placement of an
24 implant?
25 A. The implant so that we can trace it.
506
1 Q. What do you mean "the implant"?
2 A. The code of the implant.
3 Q. The code?
4 A. Yes.
5 Q. C-o-d-e?
6 A. Yes.
7 Q. What does that mean, the code of the
8 implant? Do you mean the length, the size?
9 A. No. It comes with the package that we
10 peel off from the package of the implant. We want to
11 make sure that that is inside the chart.
12 Q. So you can trace that implant?
13 A. So we can trace the implant.
14 Q. What else?
15 A. Premedication.
16 Q. What else?
17 A. Postmedication.
18 Q. What else?
19 A. Blood pressure, any kind of medication
20 or injection you have done to the patient.
21 Q. Well, how about items concerning the
22 actual surgery?
23 A. You know, not really, not for me.
24 Actual surgery writing doesn't give information.
25 Let me explain to you why. When you drill inside the
507
1 bone, you can say that -- anything you are going to
2 write is going to be subjective. So what I do
3 personally, I would try to use objective information
4 if I can use it later.
5 MR. THOMPSON: What else do you put down on the
6 chart is what Jay is trying to find out from you. Do
7 you put down a description of the procedure? What do
8 you put in there? What do you customarily put? When
9 you have performed surgery, what do you put into the
10 medical chart relative to that surgery?
11 THE WITNESS: You know, I'll tell you what I
12 do. I would try to put kind of information I can use
13 later. Like if I find some kind of bone defect --
14 MR. THOMPSON: Answer the question.
15 MR. BLOOM: I thought he was answering.
16 MR. THOMPSON: He stopped when he saw you
17 looking at Dr. Lazarof.
18 MR. BLOOM: Oh, I'm sorry.
19 THE WITNESS: I said that if I see some kind of
20 bone defect around the implant, I can write in the
21 chart "bone defect." If I look at it one year after
22 that, it is not really going to give me any kind of
23 information. So what I do sometimes is I write --
24 for Bone Defect ID, I write "Class 3 Schlooger." It
25 really gives me so much information in two or three
508
1 words. Everybody has -- as long as I can use that
2 information later, as objective as I can.
3 BY MR. BLOOM:
4 Q. How about the length of the implant?
5 Is that usually noted?
6 A. It comes with the code.
7 Q. How about the position of the implant in
8 the mouth?
9 A. That comes with the prosthetic resident
10 treatment planning, which is inside the chart.
11 Q. How about any surgical errors? Is that
12 placed in the chart?
13 A. If you detect it, yes.
14 Q. How about any unusual bone findings?
15 A. Some people, they are happy with just
16 by writing again a classification. Maybe 1, 2, 3, 4.
17 So if you read it, it may not give you information,
18 but definitely, it is giving information to the
19 people who are familiar with that classification.
20 Q. I mean, writing a chart is not just
21 about protecting yourself from malpractice cases,
22 is it, Doctor?
23 A. No, no.
24 Q. It is important to be able to know what
25 happened to a particular person in a surgery?
509
1 A. Right.
2 Q. He may need more treatment later, and
3 you want to know what happened. So we all recognize
4 the difficulties in writing everything down, but you
5 do want to make a good effort to write as much down
6 as you can under the circumstances for future
7 examination, correct?
8 A. Correct
9 Q. Was there ever a discussion with any of
10 your residents or any of your team members about what
11 type of information should be put in the chart
12 concerning the surgery? Did it ever happen where
13 immediately, you said, "Let's make sure in regard to
14 each surgery that we place the following information
15 in the chart with regard to every surgery"? Was that
16 done?
17 A. You know, I wanted to make sure that the
18 research data that I needed, to make sure that we
19 have documented that. I knew that Dr. Antin or
20 Dr. Karimzadeh are good residents. I didn't go
21 through the charts specifically with them. I know
22 when it comes to important numbers, I made sure that
23 it would be documented.
24 Q. How about the number of threads that
25 were exposed? Was that something that should be
510
1 documented?
2 MR. THOMPSON: Objection. Assumes facts not in
3 evidence.
4 BY MR. BLOOM:
5 Q. In the chart?
6 A. In the patient chart?
7 Q. Yes.
8 A. I really don't know if it has to be
9 documented there or not because when we were placing
10 the implant into the extraction socket, we were
11 counting the number of threads exposed. Its
12 morphology was different every time. So we were
13 going to write it inside the medical chart. It may
14 not give you that much information later. The size
15 of the implant is always smaller than the size of the
16 socket. So you have always some threads exposed.
Entries were made in patient records and backdated. Q. Have you ever gone into any of the study.
13 patient charts and written entries and dated them for 14 dates before the date you were making the writing?. /> 15 A. Would you please repeat your question?.
16 Q. Yes..
17 Did you ever take any patient charts and.
18 go back to those charts and write an entry and.
19 indicate that the entry had been made at a previous.
20 date when, in fact, you had just done it at that.
21 time?.
22 A. You mean to enter inside the chart in a.
23 different time?.
24 Q. Yes..
25 A. Yes, it can happen..
519
1 Q. Let's call that backdating. For
2 example, today, I might go into a chart and write
3 a notation and put the date to back in time,
4 yesterday or some other time, backdating. Did you

5 ever do that in regard to any of these charts in the 6 USC study?
7 A. I don't remember, but it can happen. 8 Q. How can that happen? 9 A. Sometimes we ask the students to leave 10 room. If they do, we go back and fill in the space.
11 Sometimes they ask, "How much space do you need?"
12 Q. Then later, you'll go back and fill in
13 that space?
14 A. Yes.
15 Q. How much time would be involved with
16 something like that? In other words, a few days you
17 might go back, a week? How far into the future might
18 you go and then come back to write something?
19 A. I really don't know.
20 Q. Could it be more than six months?
21 A. I would be surprised.
22 Q. What is the longest length of time you
23 might expect that you might actually go back and
24 write something in a space that had been left open
25 in a chart?
520
1 A. Maybe a few weeks, a few months, but
2 really, I would be surprised.
3 Q. You would say a few months would be the
4 maximum time?
5 A. Yes.
6 Q. Under what circumstances would that
7 happen where you might ask someone to leave some
8 space and go back and fill it in later?
9 A. You know, as I told you, we are a
10 teaching institute. Many times at the same time,
11 many people, they need the chart. The patient who 12 just had the surgery, for example, now is going to be
13 treated by somebody else and then is going to be
14 examined by a radiologist, and everybody needs the
15 chart. You know, it is not really unusual. It is
16 not unusual.
1 Q. You also mentioned, Doctor, in our first
2 session this morning that it sometimes happens that a
3 space might be left in a chart entry, and that you
4 might go back maybe a couple days, a couple weeks,
5 and you said maybe even as far as a couple of months
6 and that you go back and then write something in that
7 space. Do you recall that?
8 A. Yes.
9 Q. When you would do that, would you note
10 in the notation you were making that you were making
11 a notation later and inserting it back? 12 A. No.
13 Q. Do you know if the California Dental
14 Board has any rules or regulations on that topic?
15 A. I'm not familiar with that.
16 Q. You are a member of Quality Assurance;
17 is that correct?
11 Q. Did you commit any surgical errors in
12 regard to any of the implants you placed in the study
13 patients?
14 A. Would you please define "error"?
15 Q. You don't know what "error" means?
16 A. No, I don't know.
17 Q. Did you ever commit any act which you
18 thought was a mistake in some way in regard to the
19 surgeries?
20 A. I don't believe so. I don't remember.
21 Q. Did you ever write any chart entry
22 anything about any surgical errors or mistakes?
23 MR. THOMPSON: You mean words to that
24 effect?
25 MR. BLOOM: Yes. Thank you.
518
1 THE WITNESS: I don't remember.
2 BY MR. BLOOM:
3 Q. Were there ever any situations in which
4 you and Dr. Lazarof discussed whether or not a
5 surgical error or mistake was made with regard to any
6 of the study patients?
7 A. I don't remember.